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OASYS ® Surgical Technique Occipito-Cervico-Thoracic System

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Page 1: Surgical Technique - az621074.vo.msecnd.netaz621074.vo.msecnd.net/syk-mobile-content-cdn/... · OASYS Surgical Technique System Overview The OASYS Occipito-Cervico-Thoracic System

OASYS®

Surgical Technique

Occipito-Cervico-Thoracic System

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OASYS Surgical TechniqueSystem OverviewThe OASYS Occipito-Cervico-Thoracic System was developed to provide thesurgeon with versatility for the treatment of pathologies of the occipitocervicaljunction, and the posterior cervical and upper thoracic spine. The modular systemconsists of hooks, polyaxial screws and rods as well as plates and bone screws. Avariety of occiput plates and connectors complement the product line.

Multiple Polyaxial Screw Options— Standard Biased Angle— Medial Biased Angle— Smooth Shank— Cancellous— Non-Biased Angle

Cross Connector Options for AdditionalTorsional Rigidity:— Transverse Connector— Cross Connector Plate

Patented Buttress Thread Technologyto Minimize Cross-Threading

Multiple Rod Options:—Vitallium—Titanium Alloy—Commercially Pure Titanium—Transition Rods (3.5mm to 4.5, 5.5, and 6.0mm)

Biased Angle Screw Allowingfor 55º of Angulation

Variety of Laminar Hooks toBetter Match Patient Anatomy

Occipital Fixation Options— Midline Occiput Plate, Small— Midline Occiput Plate, Medium— Midline Occiput Plate, Large— Midline Occiput Plate, Large Long— Midline Occiput Plate, Mini

— 130º Occiput Plate— 130º Pre-contoured Occiput Plate, Left— 130º Pre-contoured Occiput Plate, Right— 100º Occiput Plate— 100º Pre-contoured Occiput Plate, Left— 100º Pre-contoured Occiput Plate, Right

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OASYS Surgical Technique

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Table of Contents

System Overview . . . . . . . . . . . . . . . . . . . . . 2

Implant Overview . . . . . . . . . . . . . . . . . . . . 4

Surgical Procedure . . . . . . . . . . . . . . . . . . . 11

Polyaxial Screw Placement . . . . . . . . . . . 11

Rod Placement . . . . . . . . . . . . . . . . . . . . 14

Blocker Insertion . . . . . . . . . . . . . . . . . . 16

Transverse Connection . . . . . . . . . . . . . 19

Offset & Rod to Rod Connectors . . . . . 21

Hook Placement . . . . . . . . . . . . . . . . . . . 22

Transition Rod . . . . . . . . . . . . . . . . . . . . 23

Occipital Fixation . . . . . . . . . . . . . . . . . . . 24

Midline Occiput Plate Placement . . . . . 26

Bilateral Occiput Plate Placement . . . . . 33

Implants . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Instruments . . . . . . . . . . . . . . . . . . . . . . . . 39

Stryker Spine would like to thankJohn J. Carbone, MDBaltimore, Maryland for his contribution.

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OASYS Surgical TechniqueImplant Overview

Polyaxial Screws One of the key features of the BiasedAngle Polyaxial Screw is the offset angleof the screw head, which allows forcombined divergent screw angulation of110° (or 55° in one direction).

The high degree of angulation promotesscrew placement at an optimal anatomicposition, helping to simplify the surgicalprocedure by minimizing the need forrod contouring due to linear placementof the screw heads.

There are five types of polyaxial screwsavailable in the OASYS System. (Seecomplete screw listing on page 35-37).

The standard Biased Angle Screws areavailable in diameters of 3.5mm (10 to54mm lengths in 2mm increments) and4.0mm (10 to 42mm in 2mm increments,46 and 50mm lengths). The 4.0mmBiased Angle Screws are anodized bluefor easy identification.

TheMedial Biased Angle Screws areavailable in diameters of 3.5mm (20, 22,and 24 to 40mm lengths in 4mmincrements) and 4.0mm diameters (20 to52mm lengths in 4mm increments). Thetulip heads of the Medial Biased AngleScrews are anodized green for easyidentification.

The Smooth Shank Biased Angle Screwsare available in a 3.5mm diameter (22 to40mm lengths in 2mm increments).These screws have a 10mm non-threadedshank to potentially avoid nerve root ortissue irritation. The tulip heads of theSmooth Shank Biased Angle Screws areanodized blue for easy identification.

The Cancellous Biased Angle Screws areavailable in diameters of 3.5mm and4.0mm (10 to 24mm lengths in 2mmincrements). These screws have a threadgeometry designed for purchase incancellous bone. The tulip heads of theCancellous Biased Angle Screws areanodized blue-green for easyidentification.

Medial Biased Angle Screw

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The Non-Biased Angle Polyaxial Screwsare available in diameters of 3.5mm,4.0mm and 4.5mm. The 3.5mm and4.0mm screws are 10 to 20mm in lengthin 2mm increments while the 4.5mmscrews are 20 to 52mm in length in4mm increments. The Non-Biased AnglePolyaxial Screws offer up to 30° ofangulation in each direction or 60°conical. These screws can be used ininstances where the surgeon does notneed the angulation offered with theBiased Angle Screws. A combined colorapproach has been used to identify thescrew type and diameter.

The tulip heads of the Non-Biased AnglePolyaxial Screws are anodized fuchsiawhile the 4.5mm bone screws areanodized purple.

Non-Biased Angle Polyaxial Screw

Screw Type Diameter Lengths Tulip Head Color

Biased Angle Screws 3.5mm 10 - 54mm Silver(in 2mm increments)

4.0mm 10 - 42mm, 46 and 50mm Silver(in 2mm increments)

Medial Biased Angle Screws 3.5mm 20, 22 and 24 - 40mm Green(in 4mm increments)

4.0mm 20 - 52mm Green(in 4mm increments)

Smooth Shank Biased Angle Screws 3.5mm 22 - 40mm Blue(in 2mm increments)

Cancellous Biased Angle Screws 3.5mm 10 - 24mm Blue-Green(in 2mm increments)

4.0mm 10 - 24mm Blue-Green(in 2mm increments)

Non-Biased Angle Polyaxial Screws 3.5mm 10 - 20mm Fuchsia(in 2mm increments)

4.0mm 10 - 20mm Fuchsia(in 2mm increments)

4.5mm 20 - 52mm Fuchsia(in 4mm increments)

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OASYS Surgical TechniqueHooksA variety of laminar Hooks are availableto better match the individual patient’sanatomy. Standard hooks are available infour throat heights: 3.5, 5.0, 6.5 and8.0mm. Right and left offset hooks arealso available for both right and leftapplication.

Hook, StandardShort, 5.0mm

Part # Description

48551049 Hook, Standard, 3.5mm

48551050 Hook, Standard Short, 5.0mm

48551053 Hook, Standard, 6.5mm

48551055 Hook, Standard Tall, 8.0mm

48551060 Hook, Offset Right

48551065 Hook, Offset Left

Hook, Offset Left

RodsA variety of Rod offerings are availableto provide intraoperative solutions. Foradded stiffness, Vitallium is available.Titanium and Vitallium pre-cutofferings are available with the OASYSSystem, as well as TitaniumCommercially Pure in 240mm.

Part # Description

48553080 3.5mm x 80mm Vitallium Rod

48553120 3.5mm x 120mm Vitallium Rod

48553240 3.5mm x 240mm Vitallium Rod

48553350 3.5mm x 350mm Vitallium Rod

48552025 3.5mm x 25mm Titanium Alloy Rod

48552030 3.5mm x 30mm Titanium Alloy Rod

48552040 3.5mm x 40mm Titanium Alloy Rod

48552050 3.5mm x 50mm Titanium Alloy Rod

48552060 3.5mm x 60mm Titanium Alloy Rod

48552070 3.5mm x 70mm Titanium Alloy Rod

48552080 3.5mm x 80mm Titanium Alloy Rod

48552120 3.5mm x 120mm Titanium Alloy Rod

48552240 3.5mm x 240mm Titanium Alloy Rod

48551240 3.5mm x 240mm Titanium, Commercially Pure Rod

48551350 3.5mm x 350mm Titanium Alloy Rod

Rod

Hook, Offset RightHook, Standard,6.5mm

Hook, Standard,3.5mm

Hook, Standard Tall,8.0mm

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Occipital FixationThe OASYS System offers a midlineocciput plate option as well as bilateralocciput plates to better match individualpatient anatomy.

Part # Description

48551040 130º Occiput Plate

48551041L 130º Pre-contoured Occiput Plate, Left

48551041R 130º Pre-contoured Occiput Plate, Right

48551042 100º Occiput Plate

48551043L 100º Pre-contoured Occiput Plate, Left

48551043R 100º Pre-contoured Occiput Plate, Right

48551044 Midline Occiput Plate, Small

48551045 Midline Occiput Plate, Medium

48551046 Midline Occiput Plate, Large

48551047 Midline Occiput Plate, Large Long

48551048 Midline Occiput Plate, Mini

Bone ScrewsThe following bone screws are availablefor use with the OASYS plates:

Diameter Lengths (in 2mm increments) Color

3.5mm 6 – 16mm Silver

4.0mm 6 – 16mm Blue

4.5mm 6 – 16mm Purple

Midline Straight Pre-contouredPlate Plates Plates

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OASYS Surgical TechniqueConnectorsSeveral types of Connectors areavailable in the OASYS System.

Transverse Connector

The Transverse Connector is designedfor added torsional rigidity of a bilateralrod construct. The clip-on designfeatures a very low profile and does notadd significantly to the height of theconstruct. The transverse bar is availablein 40, 60, and 80mm lengths. The bar ofthe transverse connector can be cut sothat the length can be adjusted to bettermatch individual patient anatomy.

Transverse Connector

Cross Connector Plate

Offset Connector

Part # Description

48551070 Transverse Connector, 80mm

48551071 Transverse Connector, 60mm

48551072 Transverse Connector, 40mm

Offset Connector

As an alternative to offset rodcontouring in cases of non-linear screwor hook placement, Offset Connectorscan be used to provide additionalmedial-lateral offset. The bar is availablein 12 and 20mm lengths.

Part # Description

48551073 Cross Connector Plate, 24mm

48551074 Cross Connector Plate, 32mm

48551075 Cross Connector Plate, 40mm

Part # Description

48551080 Offset Connector, 20mm

48551081 Offset Connector, 12 mm

Cross Connector Plate

In cases where screws are closertogether, this arched implant allowsconnection to the tulip heads. The archis designed for additional clearanceabove the dura and spinal cord. TheCross Connector Plate is available in24, 32, and 40mm lengths with 10mm ofadditional variability for each plate. Theplates can be bent to adapt to variablepatient anatomy.

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Rod-to-Rod Connector

The Rod-to-Rod Connector facilitatesconnection of the 3.5mm diameter rodto a spine construct using: 3.5, 4.5, 5.5,or 6.0mm diameter rods.

Parallel Rod-to-Rod Connectors

Saddle Connector 48551094

Saddle Connector

The Saddle Connector is an additionalconnector option which helps to allowconnection of the 3.5mm rod to a spineconstruct using Xia II and/or Xia 3*Polyaxial Screws. The Saddle Connectoris to allow the use of a larger size bonescrew in the thoracic area of T1 to T3per the current OASYS indications.

Part # Description

48551088 3.5mm to 3.5mm Parallel Rod-to-Rod Connector

48551091 3.5mm to 4.5mm Parallel Rod-to-Rod Connector

48551089 3.5mm to 5.5mm Parallel Rod-to-Rod Connector

48551090 3.5mm to 6.0mm Parallel Rod-to-Rod Connector

*Refer to the Xia Surgical Technique Guide for information onscrew insertion and blocker final tightening.

Parallel Connector 48551089, 48551090

Parallel Connector 48551088, 48551091

Part # Description

48551085 3.5mm to 3.5mm Axial Connector

48551084 3.5mm to 4.5mm Axial Connector

48551086 3.5mm to 5.5mm Axial Connector

48551087 3.5mm to 6.0mm Axial Connector

Axial Connector 48551084, 48551085,48551086, 48551087

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OASYS Surgical Technique

Transition Rod

The OASYS Transition Rod provides anadditional option for spanning thecervico-thoracic junction.

Transition Rods are available to connectthe following systems:• OASYS and Xia• OASYS and Xia 4.5• OASYS and SR90D

Transition Rods are offered in twodifferent rod composition options,Titanium Alloy and Vitallium for addedstiffness. Each rod is 600mm long.

Refer to the Surgical Technique for Xia,Xia 4.5, and/or SR90D for instructionson usage of the larger diameter of theTransition Rod.

Part # Description

48553600 Titanium Alloy 3.5mm-4.5mm Transition Rod

48553602 Vitallium 3.5mm-4.5mm Transition Rod

48553604 Titanium Alloy 3.5mm-5.5mm Transition Rod

48553606 Vitallium 3.5mm-5.5mm Transition Rod

48553608 Titanium Alloy 3.5mm-6.0mm Transition Rod

48553610 Vitallium 3.5mm-6.0mm Transition Rod

Transition Rod

Transition Rod Construct in situ

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Surgical Procedure

Preoperative PlanningUse the appropriate imaging techniquesto outline the patient’s osseous anatomyand to determine the proper size andtype of instrumentation to be used.Identify the components to be used forthe assembly. Keep in mind that changesto the final configuration may becomenecessary based on intraoperativefindings.

Patient Positioning andExposureThe patient is placed in the proneposition with head and neck heldsecurely in optimum alignment. Astandard midline incision is performedat the appropriate levels. The exposuremay be extended for one or two levelsbelow the inferior end of the plannedfusion to allow for easy placement of theinstrumentation.

Polyaxial ScrewPlacementFollowing exposure, penetrate the cortexwith an Awl, burr, or a drill to mark theentry point of all the screws usinganatomic, fluoroscopic, or image-guidedtechnique. To minimize the need for rodcontouring and for easy rod insertion, itis advisable to align the screw holes asmuch as possible.

In applicable anatomic areas, a PedicleProbe – followed by a Tap – can be usedto prepare the screw pathway. In allother cases, the preparation of the screwhole should follow the steps below, usingthe appropriate Drill Bit and Tap.

The Adjustable Drill Guide allows for asingle Drill Bit to be used forpreparation of variable depths. To set thedepth which corresponds to the finalscrew length, grasp knob, then rotate thelocking pin into the slot correspondingto the desired depth. Push the pinforward and lock the fixation nut at theend of the sleeve by rotating clockwise.

Awl 48562010

Adjustable Drill Guide48562011

4.5 Pedicle Probe48562115

Pedicle Probe48562118

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OASYS Surgical TechniqueIf the sleeve is not moving freely, loosenthe fixation nut before manipulating thepin. Drill depth can be adjusted whilethe Drill Bit is inserted in the AdjustableDrill Guide, however, it is notrecommended while drilling. Thefixation nut and the inner sleeve may bedisassembled for cleaning purposes.

For common screw lengths, Fixed DrillGuides are also available. These FixedDrill Guides are available for 12 and14mm screws. The 14mm guide has agold band around it for easyidentification.

Select the Drill Bit that is appropriatefor the size of the screw to be used(3.5mm, 4.0mm, or 4.5mm). The DrillBits are undersized by 1mm (i.e., the3.5mm drill has a diameter of 2.5mm),corresponding to the inner diameter ofthe screws. The Drill Bits can beattached to the Quick-Release Handleor used with standard power equipment(AO attachment).

It is recommended that a Tap be used tofinalize the preparation of the screwpathway. Taps are available in twolengths, 18mm and 54mm, and threediameters, 3.5mm, 4.0mm, and 4.5mm.There are two types of taps - cancellousand cortical - to match the thread pitchof the screws being used. The optionalTap Sleeve may be used to accuratelymeasure the tapping depth or to protectsoft tissue.

When preparing a screw hole for a screwup to 18mm, a shorter Tap option isavailable. The 18mm Tap can be used tohelp prevent contact between the cuttingedges of the Tap and soft tissue when theTap Sleeve is not used.

Note: Using incorrect Tap or Drillcombination can result in reducedbone purchase or possibility ofinstrument breakage.

Tap Sleeve4856191448561915

Fixed Drill Guide

Part # Description

48560323 2.5mm Drill for 3.5mm Polyaxial Screw

48560423 3.0mm Drill for 4.0 & 4.5mm Polyaxial Screws

Part # Description

48562034 Fixed Drill Guide, 12mm

48562035 Fixed Drill Guide, 14mm

Cortical Taps

Part # Description

48561314 3.5mm Tap, 18mm

48561414 4.0mm Tap, 18mm

48560314 3.5mm Tap

48560414 4.0mm Tap

48560514 4.5mm Tap

Part # Description

48561916 3.5mm Cancellous Tap

48561917 4.0mm Cancellous Tap

Cancellous Tap

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The Ball Tip Probe can be used to feel the integrity of thepedicle wall after drilling or tapping. The probe has a1.8mm ball tip for smaller pedicles. The Depth Gauge canbe used to confirm the screw length.

Note: The 4.0mm Drill followed by the 4.5mm Tapshould be used to prepare the pathway for the 4.5mmNon-Biased Angle Screws. Also, when preparing thepathway for the Cancellous Screws, make sure to use theCancellous Tap. The Cancellous Tap has a differentthread geometry to match the geometry of the CancellousScrews. The standard Tap Sleeve can be used with boththe 3.5mm and 4.0mm Standard and Cancellous Taps. Forthe 4.5mm Tap, use the 4.5mm Tap Sleeve.

A polyaxial screw is attached to the Polyaxial Screwdriverby placing the hex head socket over the bone screw andthreading the end of the outer sleeve into the polyaxialscrew head for stable fixation. Prior to screw implantation,use the gauges incorporated into the implant tray to verifythe screw dimensions. Aligning the Polyaxial Screwdriver inthe same axis as the screw hole facilitates screw insertion.Once the screw has been inserted, the Polyaxial Screwdrivercan be removed by unthreading the end of the sleeve fromthe screw. There is an optional outer sleeve that may beused on the Polyaxial Screwdriver. This sleeve allows youto hold the shaft of the Polyaxial Screwdriver for betterstabilization without having the polyaxial screw disengagefrom the Polyaxial Screwdriver. The sleeve can be placed onthe Polyaxial Screwdriver by holding in the button whilesliding the sleeve over the shaft.

The Locking Screwdriver provides another option forscrew insertion. The Driver attaches to the screw in thesame manner as the standard Polyaxial Screwdriver.However, the Locking Screwdriver can be locked bydepressing the tab. Once locked, the Locking Driverassembly becomes monolithic. The screw can only beloosened by rotating the Driver counterclockwise. Thisinstrument helps reduce any risk of accidentaldisengagement of the Driver from the screw during screwinsertion.

Tip: If the tip of a biased angle screw hits the bone beforethe screw is fully inserted, and the screw is unable to bedriven in further, unthread the screwdriver sleeve fromthe tulip head while leaving the hex socket engaged withthe screw to allow the screw head to spin freely and thebone screw to be driven in further.

Note: Ensure the screwdriver sleeve is tightly assembledto the Polyaxial Screwdriver shaft before attempting toattach a screw.

Note: To clean the Polyaxial Screwdriver, remove thesleeve by pressing the button. The holes in the shaft of thePolyaxial Screwdriver are designed to allow flushing ofthe instrument.

Quick Release Handle48562012

Polyaxial Screwdriver48562018

Tap Sleeve4856191448561915

Polyaxial Screwdriver with optional outer sleeve detached

Locking Screwdriver48563016

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OASYS Surgical TechniqueTo minimize the potential for rigidlocking and limiting the range ofangulation, do not seat the screw head tootightly to the bone. Should the screw headbecome locked to the bone screw, use theScrew Head Adjuster to break the lock. Ifneeded, the screw may be backed outabout half a turn to allow for the head tomove freely.

If it becomes necessary to remove a screw,begin by unthreading the bone screw withthe hex portion of the PolyaxialScrewdriver, and then reattach the outersleeve to complete the removal.

For additional height adjustments to thescrew, the Poly Adjustment Driver can beused in place of the Polyaxial Screwdriver.This instrument has the same internal hexas the Polyaxial Screwdriver, but has nosleeve to impede vision.

Rod PlacementOnce all the bone screws and hooks havebeen inserted and aligned, a RodTemplate is available to estimate therequired rod length and contour. If thescrew heads need to be aligned in a morelinear fashion, the Screw Head Adjustercan be used for this purpose. Because ofthe angle of the biased cut and thecorresponding range of angulation of thescrew, it is recommended that the notchedlines on the screw head face in thedirection in which the maximum bonescrew angulation is desired (correspondsto the smallest angle between the screwand the rod). All screws should be alignedprior to rod and blocker insertion asfurther adjustments will become difficultonce the construct has been assembled.

To prepare the Rod/Plate Cutter for rodinsertion, move the handles into the“open” position as indicated with thelaser-marked arrows. Insert the rod intothe head of the Rod/Plate Cutter from theside with the laser-marked arrows, andcompress the handles as indicated. Sincethe rod will be cut slightly below thesurface of the cutting head, there will beapproximately 3mm added to the rodlength from the point of insertion. It is

Screw Head Adjuster48560021

Rod Template48560017

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recommended that the rod be cut to thedesired length prior to contouring as it maybecome difficult to cut a rod that hasalready been bent.

Note: Lubrication of the Rod/Plate Cutteris required to maintain ease of use of theinstrument.

Note: If using the Rod/Plate Cutter on aTransition Rod this instrument shouldonly be used on the 3.5mm diameterportion of the rod and not on the largerdiameter or transition zone.Please reference the Surgical Techniquedocuments for Xia, Xia 4.5, and SR90D forinstructions on how to cut the largerdiameter portion of the Transition Rodusing the appropriate instrumentation.

A simple, “pin cutter” style Small RodCutter is also available to cut the rods. Thiscutter is for 3.5mm diameter rods only.

Using the Rod/Plate Bender (the side withthe round bending iron), the rod can becontoured to match the sagittal alignmentof the spine as well as the coronalorientation of the screws. Avoid sharp,excessive, or repeated bending of the rod tomaintain material integrity. Prior toimplantation, inspect the rod for anydamage (e.g., notching) it may havesustained during preparation.

If damaged, use new rod. In-situ Bendersare also available for additional contouradjustments.

Once the rod has been shaped to its finalconfiguration, introduce the rod into thescrew heads using the Rod Forceps.

The Rod Rotation Forceps allow for minorrod rotation maneuvers. The tips haveserrated teeth for better grip on the rod.

Rod/Plate Cutter48560018

Rod Plate Bender48560019

In-situ Benders48560022 - Right48560023 - Left

Rod Rotation Forceps48561039

Small Rod Cutter48561038

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OASYS Surgical TechniqueBlocker InsertionThere are six options for insertion and alignment of the Blockers:

1. Corkscrew Persuader and Hexdriver2. Locking Persuader and Hexdriver3. Persuader and Hexdriver4. Insertion Tube and Hexdriver5. Rod/Blocker Inserter and Hexdriver6. Hexdriver by itself

To facilitate rod insertion, any of the three typesof persuaders may be applied to fully seat therod into a tulip head. While keeping thepersuader aligned with the course of the rod,slide the tip of the instrument over a tulip headto persuade the rod into the tulip head. Theshaft of the Persuader is cannulated to allow forthe passage of the Hexdriver and engagementof the blocker while the Persuader is in place.

Note: The Persuader, Locking Persuader, andCorkscrew Persuader are not used for spinalcorrection.

Note: Any Persuader must be properly seatedbefore any application of force.

The Corkscrew Persuader has an inner shaftthat engages the tulip head of an implant andan outer shaft that reduces a rod upon turningthe T-handle. The window at the most distalend of the outer shaft is intended to help allowfor visualization of the blocker and Hexdriverwhile being inserted through the persuader.

To assemble the Corkscrew Persuader, slide theT-handle onto the distal end of the inner shaftuntil the T-handle meets the threads. Turn theT-handle counterclockwise until it is fullythreaded, then slide the Inner Shaft/T-handleassembly into the Outer Shaft while aligning thelaser mark lines on the inner and outer shaftsuntil the inner shaft is exposed. The distal tip ofthe inner shaft will mate with the distal tip ofthe outer shaft when properly assembled.

To connect the Corkscrew Persuader to a tuliphead, ensure the distal end of the inner shaft isfully exposed by pulling upward on the blue,Stryker-branded handle so that it is meets theT-handle. Keep the blue handle connected tothe T-handle while attaching the instrument tothe implant tulip head. Once the instrument isfully seated on the tulip head, turn the T-handleclockwise to drive the outer shaft onto the roduntil the rod is seated. A laser mark line on theinner shaft will appear within the window

Persuader48560024

Corkscrew Persuader48562024

Locking Persuader48561024

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Insertion Tube/Anti-Torque Key48562027

Locking Persuader48561024

labeled “ROD SEATED” on the outer shaft toconfirm that the rod is seated enough toallow for blocker insertion.

Note: The T-handle will freely rotate oncethe instrument’s maximum amount ofpersuasion is achieved.

After provisionally tightening the blocker tothe tulip head, remove the instrument fromthe construct by slightly lifting up on the bluehandle while turning the T-handlecounterclockwise. Continue to turn the T-handle counterclockwise until it stops.Avoid turning the T-handle further once itbottoms out. Keeping the T-handle and bluehandle together, simultaneously lift and twistthe persuader to disengage the instrumentfrom the construct.

Disassemble the corkscrew persuader bypinching the distal tip of the inner shaft whilepulling the inner shaft out of the outer shaft.Unscrew the T-handle from the inner shaft tocomplete disassembly.

The Locking Persuader has two bars thatpush down on both sides of the rod. It alsohas a ratcheted trigger design that locks theLocking Persuader arms and allows you tomaintain the rod reduction without requiringa tight grip on the trigger. When attaching tothe screw head, align the side windowsparallel to the rod. To disengage, press thethumb release button, rotate the LockingPersuader slightly to either side, and gentlypull it off the screw head.

When using the non-locking Persuader,pressure must be maintained on the triggerwhile the blocker is inserted. To disengage,release the trigger, rotate the Persuaderslightly to either side, and gently pull it offthe screw head.

As an alternative to using the Persuader, thecannulated Insertion Tube/Anti-Torque Keycan be used to push the rod down into thescrew head and align the PolyaxialScrewdriver during blocker insertion. Aspecially designed ring on the inside of theInsertion Tube provides an interference fitwith a fully inserted Hexdriver to potentiallyreduce the risk for an accidental disassembly.It is recommended to hold both instrumentsduring their removal from the rod construct.

Persuader48560024

Persuader seating rod intothe tulip head of the screw

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Load the blocker firmly onto the tip of the Hexdriver andplace it into the screw head, using the cannulated instrumentsas guides or in a free-hand manner. For proper loading ontothe Hexdriver, the blockers should be stored in the tray withthe laser-marked line facing up. The buttress thread design ofthe blocker and proper alignment of the Hexdriver minimizethe potential for cross-threading.* Turning the blockercounter-clockwise about a quarter turn when first introducedfacilitates the insertion into the screw head or hook. Whenused with the Persuader or with the Insertion Tube, lasermarkings on the Hexdriver aid in visually assessing the depthof blocker insertion. The lower of the two lines indicates thelevel at which the blocker engages the screw head; theHexdriver should be removed when the upper laser markinghas been reached.

The Rod/Blocker Inserter is another option that can insertthe rod directly in the tulip head and is cannulated to allowblocker insertion. Place the Inserter over the rod and pressdown to snap into place. Then grab the desired tulip headwith the Inserter. Position the tulip head as desired using theInserter instrument. Insert the blocker with the Hexdriverthrough the cannula of the Inserter.

Note: The laser markings on the Hexdriver do notcorrespond with the Rod/Blocker Inserter.

Note: The Hexdriver should be used for blockerinsertion and provisional tightening only. Do not performfinal tightening with the Hexdriver as it will result indamage to the instrument over time and incorrect finalimplant torque.

Once all of the blockers have been inserted, the InsertionTube or the Persuader, in combination with the TorqueWrench or Audible Torque Wrench, should be used for finaltightening. The blocker is completely tightened when the twoarrows on the shaft of the Torque Wrench are aligned, whichcorresponds to 3Nm. The blocker is completely tightened to3Nm when the Audible Torque Wrench clicks once.

Note: The Audible Torque Wrench must be disposed ofafter use in surgery. It cannot be sterilized.

Note: It is important to tighten the blocker to therecommended torque to ensure future integrity of theconstruct. Tightening under or over the torque limit isinadvisable and should be avoided. Appropriate counter-torque must be applied with the Insertion Tube orPersuader.

Should compression of the adjacent instrumented levels bedesired prior to final blocker tightening, it can be achieved byplacing the Compressor over the neighboring screw heads orhooks and using the ratchet mechanism to adjust the amountof compression needed. Similarly, the Distractor may beused to achieve distraction of adjacent levels. *Data on file at Stryker Spine

Compressor48561026

Distractor48561041

Hexdriver48561042

Blocker48551000

Rod/Blocker Inserter48562100

Torque Wrench48562028

Audible Torque Wrench 48561028

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The Transverse Connector attachesdirectly to the rod resulting in a lowprofile construct. To insert, measure thedistance between the rods, cut theconnector bar with the Rod/Plate Cutterto the appropriate length (distancebetween the rods plus 10mm foradequate fit within the connector clip),and pre-load both connector clips ontothe connector bar. If the bar iscontoured with the Rod/Plate Bender,use the appropriate precautions asdescribed previously.

Note: Usage of the Connector ClipInserter is strongly recommended toneutralize the forces needed forassembly and prevent damage toimplant.

Note: Transverse Connectors andCross Connector Plates should only beused on the 3.5mm diameter portion ofa Transition Rod and not on the largerdiameter or transition zone.

Place the hooked part of the ConnectorClip Inserter under the rod, position theconnector on the pin protruding fromthe sliding upper shaft, and snap the cliponto the rod by squeezing theConnector Clip Inserter handle. Repeatthe insertion steps for the contra-lateralclip. Check that the connector barprotrudes outside both clips for properlocking. To secure both clips in theirfinal position, the Insertion Tube incombination with the Torque Wrenchshould be used for final tightening. Therecommended torque value is the sameas for the blockers: 3Nm.

If the Transverse Connector needs to beremoved from the rod construct, removethe set screws from both clips using theHexdriver and pull out the transversebar. By advancing the Connector ClipRemover into the head of the clip, theclip will be released from the rod.

Transverse ConnectionTwo options are available for transverse connection to offer additionaltorsional rigidity for bilateral constructs:

1. Transverse Connectors2. Cross Connector Plates

Transverse Connector

Connector Clip Remover48560129

Connector Clip Inserter on bone

Connector Clip Inserter48560029

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OASYS Surgical TechniqueThe Cross Connector Plate attaches to thetulip heads to accommodate narrow spacesbetween the screws. When using this type ofconnector, you must use a connector plateblocker instead of the standard blocker totighten the rod to the two screws where youwish to make the transverse connection. Alocking nut is then used to tighten the plateonto the identified tulip heads.

In preparation to place the cross connector, youmay choose to remove the preassembled crossconnector nuts manually or by using the CrossConnector Nut Inserter. The Cross ConnectorNut Inserter holds two nuts, one on each end.After the nuts have been removed from theCross Connector Plate and are being held bythe Cross Connector Nut Inserter, place thestandard blockers on all screws except wherethe cross connector will be used. Insert theconnector plate blockers onto those tulip headsusing the Hexdriver.

Note: The Persuaders do not fit over theconnector plate blockers. Thus, if persuasionis needed, the Persuader or Insertion Tubemust be attached to the tulip heads of thelevels adjacent to the cross connectorplacement.

Once the rod placement is verified, performfinal tightening on all blockers. For finaltightening of the connector plate blockers,place the Torque Wrench on the blocker andplace the Anti-Torque Key on an adjacent level.

Next, choose the appropriate size ConnectorPlate (24, 32, or 40mm) by measuring thedistance between the rods. The ConnectorPlate’s screw hole is slotted to accommodate upto an additional 10mm of distance between therods. You can further contour the ConnectorPlate using the Connector Plate Bender. Tobend the Connector Plate, slide one side of theplate fully into the first bender (benders areexactly the same—there is no left or right).Then slide the other side of the plate into thesecond bender. To straighten the arch, insertthe plate with the arch facing down. To increasethe bend, insert the plate with the arch facingup. You can also apply a slight twist as needed.

Note: To maximize strength of the construct,it is important that the Connector Plate layflatly on the blockers. If the Connector Platedoes not fit properly, contour the plate usingthe Connector Plate Benders.

Extended blocker placed onto medial-biased tulip head.

Anti-Torque Key is placed at adjacent level. Finaltighten to 3Nm with Torque Wrench.

Bend Cross Connector Plate, if necessary.

Use Cross Connector Nut Inserter to remove preassembledcross connector nuts.

Cross Connector Nut Inserter

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Next, lay the Connector Plate on the connectorplate blockers; then put the nuts on the plate.

There are two options for inserting the nuts:

1. Locking Nut Socket and Torque Wrench

Attach the Locking Nut Socket to the TorqueWrench, and use the assembled instrument toplace the locking nut over the Connector Plate.After verifying the correct fit of the ConnectorPlate, tighten the locking nuts by attaching theAnti-Torque Key to the adjacent tulip head andaligning the Torque Wrench arrows to achieve the3Nm torque.

2. Cross Connector Nut Inserter, Cross ConnectorNut Tightener and Torque Wrench

Using the Cross Connector Nut Inserter, seat thenuts on the Cross Connector Plate. Next, attachthe Cross Connector Nut Tightener to the TorqueWrench, and use the assembled instrument tofinal tighten the nuts to 3Nm by attaching theAnti-Torque Key to the adjacent tulip head.

Offset and Rod-to-RodConnectorsIn cases in which the patient’s anatomy requiressignificantly different lateral or medial screwpositions, Offset Connectors may be used tofacilitate rod attachment.

The bar of the Offset Connector is available intwo sizes: 12mm and 20mm. The 12mm lengthallows for up to 4mm of offset from the axialalignment, while the 20mm connector will allowfor up to 12mm. If desired, the bar can beshortened by using the Rod/Plate Cutter asdescribed previously.

The Rod-to-Rod Connectors are available toconnect the system to a construct with a 6.0, 5.5,4.5, or 3.5mm diameter rod. All four sizes areavailable in a side-to-side and axial version. It isrecommended that the Rod-to-Rod Connector bepreloaded on the larger rod: Xia or SR90D. Slidethe 3.5mm rod into the connector, and then usethe Hexdriver to provisionally tighten theconnector set screws to secure the assembly inplace.

The Torque Wrench must be used for finaltightening of all connector set screws. Therecommended torque value is the same as for theblockers: 3Nm.

Attach Locking Nut Socket to Torque Wrench.

Offset Connector

Parallel Rod-to-Rod Connectors

Axial Connector

Attach Cross Connector Nut Tightener toTorque Wrench.

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OASYS Surgical TechniqueNote: The connector set screws usedin the Transverse, Offset, and Rod-to-Rod Connectors are smaller than theblockers used with the PolyaxialScrews, Hooks, and Occiput Plates.Connector set screws and blockers arenot interchangeable.

Saddle Connector

The Saddle Connector is available toconnect the OASYS Occipital-Cervico-Thoracic System to a construct withXia II or Xia 3 Polyaxial screws.* TheSaddle Connector is designed to allowthe use of a larger size bone screw in thethoracic area of T1 to T3 per thecurrent OASYS indications.

To use the Saddle Connector, firstfollow the surgical technique for screwinsertion for the Xia II or Xia 3polyaxial screws and the OASYS surgicaltechnique for placement of OASYSpolyaxial screws. Place the OASYSSaddle Connector in the tulip-head ofthe Xia screw. The Saddle Connectorshould be facing upwards in a U-shape.Introduce the OASYS rod into theSaddle Connector of the Xia screw andinto the adjacent OASYS tulip heads.Fix the rod to the screw using standardXia blockers in the Xia screw tulip headsand standard OASYS blockers in theOASYS screw tulip heads.

Hook PlacementLamina preparation and hook sizetemplating is facilitated by using theHook Preparer. The two blades of theHook Preparer – one on each end –correspond to the short and tallstandard hook blades.

Select the appropriate Hook and use theHook Forceps to place it into position.

For rod sizing, contouring, andinsertion as well as final constructfixation (i.e., blocker insertion), followthe steps described in the section onPolyaxial Screws above.

Hook Forceps48560033

*Refer to the Xia Surgical Technique Guide for information onscrew insertion and blocker final tightening.

Hook Preparer48560032

Saddle Connector in Polyaxial Screw

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Transition RodThe OASYS Transition Rod is anotheroption for creating constructs that span thecervico-thoracic junction. Transition Rodsallow constructs to be created using theOASYS Occipital-Cervico-Thoracic Systemand Xia, Xia 4.5, or SR90D systems.

To use the Transition Rod, first follow theXia, Xia 4.5, or SR90D surgical techniquefor pedicle screw insertion. Next follow theOASYS surgical technique for hookplacement in the cervical spine and/orpolyaxial screw placement in the upperthoracic spine. After the cervico-thoracicfixation points have been placed, select theappropriate diameter and materialTransition Rod and cut and contour the rodto accommodate the patient’s anatomy. Tocut the 3.5mm portion of the TransitionRod, use the OASYS Rod/Plate Cutter orSmall Rod Cutter. To cut the largerdiameter portion of the Transition Rod, usethe appropriate rod cutters from the Xia,Xia 4.5 or SR90D systems. To contour the3.5mm portion of the rod, use the OASYSRod/Plate Bender. To contour the largerdiameter portion of the rod, use theappropriate rod benders from the Xia, Xia4.5, or SR90D systems.

Align the Transition Rod so that the 3.5mmdiameter portion sits in the OASYS tulipheads and the larger diameter (4.5, 5.5, or6.0mm) portion sits in the Xia, Xia 4.5 orSR90D tulip heads. Follow the OASYSsurgical technique for fixation of the3.5mm portion of the rod using the OASYSblockers and the respective Xia, Xia 4.5, orSR90D surgical techniques for fixation ofthe larger portion of the rod.

Note:Do not place hooks or screws in therod's transition zone as this can lead toincomplete fastening of the hooks/screwsto the rod.

Note: All OASYS instruments, connectors,hooks, and blockers should be utilized onthe 3.5mm portion of the Transition Rodand not on the transition zone or the rod'slarger diameter.

Note: The 3.5mm portion of the OASYSTransition Rod is not intended to be usedbeyond T3.

Transition Rod

Transition Rod Construct in situ

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OASYS Surgical Technique

* Mini can be specially ordered

Part # Description

48551044 Midline Occiput Plate, Small

48551045 Midline Occiput Plate, Medium

48551046 Midline Occiput Plate, Large

48551047 Midline Occiput Plate, Large Long

48551048 Midline Occiput Plate, Mini

Occipital Fixation

Implant Overview

OASYS implants are intended for use asan aid in spine fusion. Use with bonegraft is recommended.

Bone Screws

The following bone screws are availablefor use with the OASYS plates:

Midline Occiput Plates

The OASYS system features a MidlineOcciput Plate. This single plate allowsfor positioning directly on the midlinekeel of the occiput.

The Midline Occiput Plate is uniquelydesigned to contour to the patient’sanatomy to reduce the need or amountof rod-contouring. The plate is availablein four standard sizes*: Small, Medium,Large and Large Long. The implant hasa plate body that attaches to the occiput,two legs that extend the plate to thecervical spine and two feet that hold therod-to-plate connection. The four sizesvary in length and width of the platelegs. The body and feet of the plateremain constant.

Diameter Lengths (in 2mm increments) Color

3.5mm 6 – 16mm Silver

4.0mm 6 – 16mm Blue

4.5mm 6 – 16mm Purple

Midline Occiput Plate

Midline Plate Midline Plate, Mini

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*The Mini plate offers two points of midline fixation

Implant Design Features

Plate Body

• Allows five points of fixation to theocciput, three points on the midline*,and two additional points at thesuperior lateral end

• Can be contoured in the sagittal andcoronal planes to adapt to varyingoccipital anatomy

• Curved shape at the top of the plate isdesigned to be positioned just beneaththe inion, and is constant for all sizes

• Hole configuration is the same for allsizes, allowing for interchangeability ifneeded.

Plate Legs

• Extend the plate to the cervical spine tohelp reduce rod contouring

• Length and width vary (See Table 1)• Width of the legs should match thewidth of the cervical fixation points asbest as possible to minimize rodcontouring

• Can be contoured in the sagittal andcoronal planes to adapt to varyingoccipital anatomy

Plate Feet

• Designed to sit above the ring of C1, inline with the cervical fixation points

• Pre-angled at 130° (cannot becontoured further)

• Polyaxial tulip head connects the rodto the plate, and offers 26° ofvariability in each direction

Part # Description Length Width # Holes

48551044 Midline Occiput Plate, Small 37 30 5

48551045 Midline Occiput Plate, Medium 40 38 5

48551046 Midline Occiput Plate, Large 45 43 5

48551047 Midline Occiput Plate, Large Long 49 43 5

48551048 Midline Occiput Plate, Mini* 33 27 4

Table 1

*Special Order

width

length

Width is measured from thecenter of one polyaxial tulip tothe center of the secondpolyaxial tulip.

Length is measured from thetop of the plate to the base ofthe foot in the plate.

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OASYS Surgical Technique

Midline Occiput Plate Placement

The midline occipital plate is uniquelydesigned to contour to the patient'sanatomy. The base of the plates is pre-bentto 130° and has polyaxial heads designed tooptimize the connection to the cervicalfixation points. To reduce long momentarms and minimize the stress on theconstruct, it is recommended to minimizethe length between the fixation points on therod and maximize the number of cervicalfixation points. More fixation points allowfor better load sharing. Distributing theloads reduces the stress on the individualparts.

1. Select Plate Size

The proper Occiput Plates should beselected allowing application immediatelybelow the level of the inion. Size selectionshould attempt to minimize the distancebetween the polyaxial heads of the plate andthe cervical fixation point. The pre-angledfeet of the plate are designed to sit above thering of C1.

Note: A short distance between fixationpoints reduces bending moments thusreducing stress on the fixation points.

2. Plate Contouring

To contour the Midline Occipital Plate usethe Occiput Plate Bending Irons. TheOcciput Plate Bending Irons can be used ina variety of positions. Plates should becontoured to better accommodate thepatient’s occipital anatomy.

Warning: It is important to avoid excessiveplate bending, especially over the midlinescrew holes.

Occiput PlateBending Irons48561049

Midline Plate Midline Plate, Mini

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The midline plate can be bent in boththe coronal and sagittal planes.

To contour plate to the patient'soccipital anatomy, first bend the legs ofthe plate (Image 1 and 2) in the sagittalplane.

To bend plate legs, place the mouth ofone bender over the superior portionof the plate leg and the legs of thebender over the adjacent leg of theplate. Benders are marked “TO BENDLEGS ONLY” (Image 3).

Warning:Do not bend the angled footof the plate as excessive bends caneffect the integrity of the constructand/or damage the polyaxial tuliphead.

Image 1

Image 2

Image 3

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OASYS Surgical TechniqueContinue to produce a symmetricalbend on the adjacent side, if necessary(Image 2).

To create a sagittal bend of the platebody, place the head of the bender onthe head of the plate. Place the mouthof the other bender on the inferiorportion of the plate body (Image 4).

To create a coronal bend, hold bothbenders with the mouth facing upwards.Benders should align (Image 5) tocontour the plate down the midline.Bend of the plate body should alignwith final contour of the plate legs.

Tip: Holding the far ends of thebending iron helps to contour the plateappropriately.

It is important to avoid point bending(Image 6) as excessive bending candamage the plate resulting in platebreakage.

Warning:Do not repeatedly bend theplate. Care should be taken to notmake extreme bends so as to avoidstress concentrations on the plate.

Image 2

Image 4

Image 5

Image 6

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Screw Placement

a) Use the Awl to penetrate the cortexand mark the bone screw entry point.

b) Drill depth should be determinedbased on approximating the thicknessof the occiput from preoperativeimaging and based on the anatomy.Drilling should be performedthrough the Occiput Plate using theappropriate Drill Guide. Two-sidedOcciput Fixed Drill Guides areavailable in depths of 6 & 8mm, 10 &12mm, 14 & 16mm and can be usedwith all diameter screws.

Note: It is recommended to Drill asclose to full thickness into the occiputas can be safely performed. Drill depthshould be determined based onapproximating the thickness of theocciput from preoperative imaging andbased on patient anatomy. Drillingshould be performed through theOcciput Plate with the Drill Guide set.

Awl48562010

Occiput Fixed Drill Guide

Part # Description

48561044 Occiput Fixed Drill Guide, 6 & 8mm

48561045 Occiput Fixed Drill Guide, 10 & 12mm

48561046 Occiput Fixed Drill Guide, 14 & 16mm

Plate Holder48510300

Plate Holder on bone

Plate Placement

Use the Plate Holder to hold plate inposition below the level of the inionwith the polyaxial heads of the plateabove the ring of C1 in line with thecervical fixation points. With the PlateHolder in place, implant the bonescrews.

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OASYS Surgical TechniqueScrew Corresponding Corresponding Diameter Drill Tap

3.5mm 2.5mm Drill Occiput Set Tap, 3.5mm485543(06-16)* 48565323 48561053

4.0mm 3.0mm Drill Occiput Set Tap, 4.0mm485544(06-16)* 48565423 48561054

4.5mm 3.5mm Drill Occiput Set Tap, 4.5mm485545(06-16)* 48565523 48561055

*2mm increments

The Occiput Drill Bits are available inthree diameters and are color-coded tomatch the corresponding screwdiameters: • 2.5mm Drill for 3.5mm Screw• 3.0mm Drill for 4.0mm Screw• 3.5mm Drill for 4.5mm Screw

Drill Bits can be attached to the ShortQuick Release Handle for manualdrilling. Alternatively, you can attach theDrill Bits to a power drill using eitherthe Flexible Shaft or the Straight Shaft.

Warning: Be sure to use thecorresponding Drill and Tap. Using asmaller diameter Drill can result inTap breakage. Tapping in a hole toosmall can result in a sheared tap.

c) Attach the appropriate sized OcciputSet Tap (color-coded to match thescrew diameter) to the Short QuickRelease Handle, and be sure to tapthe entire length of the hole.Measure the length tapped to ensureappropriate screw length.

Flexible Shaft48561051 Straight Shaft

48561056

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3. Contour Rod

Contour the rod as required, using theRod/Plate Bender. For a more acuteangle, you may also bend the rods usingthe small holes of the Occiput PlateBending Irons.

Note: If bending the larger diameterportion of a Transition Rod please referto Surgical Technique documentationfor Xia, Xia 4.5, and/or SR90D forappropriate instrument usageinstructions.

Note: It is important to contour therod to the curvature of the spine.Failure to do so could result in excessiveloading of the construct.

Occiput PlateBending Irons48561049

d) Insert the bone screw using the ShortDriver, Angled Driver or theHexdriver. No matter which driver isused to initially insert the bone screw,it is recommended that the ShortDriver be used for final tightening.Three or more of screws should beused.

Angled Driver48561043

Short Driver48561050

Hexdriver48561042

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Hexdriver inserts blocker into polyaxial tulip.

Lay the rod into the tulip heads of theOcciput Plate and the cervical fixationpoints. The rod is fixed to the OcciputPlate with the standard blocker. Insertthe blockers with the Hexdriver, utilizingthe Persuader and/or Insertion Tube asnecessary. Final tighten all blockers onthe cervical fixation points to 3Nm. TheRod must extend through the polyaxialhead but should not touch the plate legsfor proper fixation.

Use the Anti-Torque Key and TorqueWrench or Audible Torque Wrench onthe polyaxial heads. The standardblocker, which should be tightened bythe Torque Wrench to 3Nm, is used tosecure the plate-to-rod assembly.

Note: Crosslinks are recommended tobe placed close to the plate/rod fixationpoints to increase construct stabilityand stiffness.

Final tighten blocker to 3Nm.

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Rod/Plate Cutter48560018

Both the 100° and 130° plates are offeredin a “left” and “right” pre-contouredversion. The plates have approximately a30° radius, and cannot be contouredfurther in the frontal plane using theRod/Plate Bender.

Note: The pre-contoured BilateralOcciput Plates cannot be cut.

To prepare the Rod/Plate Cutter forStraight Occiput Plate insertion, movethe handles into the “open” position asindicated with the laser-marked arrows.Insert the plate into the slot in the headof the Rod/Plate Cutter from the sidethat contains the laser marking (arrow),and position it so that the bendinggroove between holes lines up with theend of the small gauge block situatedabove the insertion slot. This positionallows the plate to be cut through thearea between holes. Compress thehandles as indicated by the arrow toshorten the plate.

Note: If plate is overcontoured inlateral direction, replace with newimplant.

Bilateral Occiput PlatePlacementThe OASYS system also features bilateralplates that can be contoured as requiredto the patient’s anatomy. Both straightand pre-contoured Occiput Plates areavailable in 100° and 130° foot angles.

The Occiput Plates feature four roundanchor holes and one slot, as well as afoot, which connects the plates into arod construct in the cervical spine. Theangle minimizes the amount of rodcontouring necessary in the sagittalplane to fit the implants. Bilateral Occiput Plates

Part # Description

48551040 130º Occiput Plate

48551041L 130º Pre-contoured Occiput Plate, Left

48551041R 130º Pre-contoured Occiput Plate, Right

48551042 100º Occiput Plate

48551043L 100º Pre-contoured Occiput Plate, Left

48551043R 100º Pre-contoured Occiput Plate, Right

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OASYS Surgical TechniqueUsing the Bilateral Occiput Plate BendTemplate, determine the desiredposition and contour of the implant.The side of the Rod/Plate Benderwithout the round bending iron is usedto bend the plate in the frontal plane.Slide the plate in the undercut portionof the top bending arms and positionthe bending tip between the plate holes.Once bent in the frontal plane, the plateshould never be reverted to its originalshape as it would compromise itsstrength.

The opposite side of the Rod/PlateBender with the round bending iron isused to bend the plate in the sagittalplane. It is recommended that the platebe bent gradually from both sides and toavoid excessive contouring, which maycompromise the plate material integrity.Bending the plate in the area betweenthe screw holes minimizes deformationof the screw holes and allows properscrew fit.

Note: The plate should always be bentin the frontal plane first. The plateshould not be contoured more than 8°per segment. If plate is damaged oroverbent, replace implant.

When the plate has been contoured toits desired shape and placed in positionwith the Plate Holder, use it as a guideto mark the entry points for the pilotholes with the Awl. As an alternative, theblue plate template can also be used forthis purpose. Proceed with drilling theholes, using the Drill Guide and theappropriate size Drill (3.5, 4.0 or4.5mm, depending on the diameter ofthe screw to be used). Drill depth shouldbe determined based on approximatingthe thickness of the occiput frompreoperative imaging and based on theanatomy. Drilling should be performedthrough the Occiput Plate with the DrillGuide set to the appropriate length. Thehole should then be tapped.

Rod/Plate Bender48560019

Sagittal bending with Rod/Plate Bender

Plate Holder and Awl

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To connect the Occiput Plate to acervical construct, it is recommendedthat the plate be pre-assembled onto therod prior to implanting the plate. Thestandard blocker, which should betightened by the Torque Wrench to3Nm, is used to secure the plate-to-rodassembly. Connect the plate to the rodprior to putting in the bone screws.

Position the final plate implant, andinsert and final tighten the occiput bonescrews with the Angled Driver,Hexdriver or Short Driver.

For increased stiffness and strength, anadded Vitallium rod option is available.

Part # Description

48553080 3.5mm x 80mm Vitallium Rod

48553120 3.5mm x 120mm Vitallium Rod

48553240 3.5mm x 240mm Vitallium Rod

48553350 3.5mm x 350mm Vitallium Rod

Note: For increased constructstrength, at least two bone screwsshould be placed in any of the fouranchor holes. A bone screw should alsobe inserted into the slot at the base ofthe plate for a total of at least threescrews in each plate. Crosslinks arerecommended to increase constructstability and stiffness.

Insert blocker into plate with Hexdriver

Vitallium Rod

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OASYS Surgical Technique

Implants

Part # Description

Biased Angle Screws48552310 3.5mm x 10mm Biased Angle Screw48552312 3.5mm x 12mm Biased Angle Screw48552314 3.5mm x 14mm Biased Angle Screw48552316 3.5mm x 16mm Biased Angle Screw48552318 3.5mm x 18mm Biased Angle Screw48552320 3.5mm x 20mm Biased Angle Screw48552322 3.5mm x 22mm Biased Angle Screw48552324 3.5mm x 24mm Biased Angle Screw48552326 3.5mm x 26mm Biased Angle Screw48552328 3.5mm x 28mm Biased Angle Screw48552330 3.5mm x 30mm Biased Angle Screw48552332 3.5mm x 32mm Biased Angle Screw48552334 3.5mm x 34mm Biased Angle Screw48552336 3.5mm x 36mm Biased Angle Screw48552338 3.5mm x 38mm Biased Angle Screw48552340 3.5mm x 40mm Biased Angle Screw48552342 3.5mm x 42mm Biased Angle Screw48552344 3.5mm x 44mm Biased Angle Screw48552348 3.5mm x 48mm Biased Angle Screw48552350 3.5mm x 50mm Biased Angle Screw48552352 3.5mm x 52mm Biased Angle Screw48552354 3.5mm x 54mm Biased Angle Screw

48552410 4.0mm x 10mm Biased Angle Screw48552412 4.0mm x 12mm Biased Angle Screw48552414 4.0mm x 14mm Biased Angle Screw48552416 4.0mm x 16mm Biased Angle Screw48552418 4.0mm x 18mm Biased Angle Screw48552420 4.0mm x 20mm Biased Angle Screw48552422 4.0mm x 22mm Biased Angle Screw48552424 4.0mm x 24mm Biased Angle Screw48552426 4.0mm x 26mm Biased Angle Screw48552428 4.0mm x 28mm Biased Angle Screw48552430 4.0mm x 30mm Biased Angle Screw48552432 4.0mm x 32mm Biased Angle Screw48552434 4.0mm x 34mm Biased Angle Screw48552436 4.0mm x 36mm Biased Angle Screw48552438 4.0mm x 38mm Biased Angle Screw48552440 4.0mm x 40mm Biased Angle Screw48552442 4.0mm x 42mm Biased Angle Screw48552446 4.0mm x 46mm Biased Angle Screw48552448 4.0mm x 48mm Biased Angle Screw48552450 4.0mm x 50mm Biased Angle Screw

Part # Description

Medial Biased Angle Screws48555320 3.5mm x 20mm Medial Biased Angle Screw48555322 3.5mm x 22mm Medial Biased Angle Screw48555324 3.5mm x 24mm Medial Biased Angle Screw48555328 3.5mm x 28mm Medial Biased Angle Screw48555332 3.5mm x 32mm Medial Biased Angle Screw48555336 3.5mm x 36mm Medial Biased Angle Screw48555340 3.5mm x 40mm Medial Biased Angle Screw

48555420 4.0mm x 20mm Medial Biased Angle Screw48555422 4.0mm x 22mm Medial Biased Angle Screw48555424 4.0mm x 24mm Medial Biased Angle Screw48555428 4.0mm x 28mm Medial Biased Angle Screw48555432 4.0mm x 32mm Medial Biased Angle Screw48555436 4.0mm x 36mm Medial Biased Angle Screw48555440 4.0mm x 40mm Medial Biased Angle Screw48555444 4.0mm x 44mm Medial Biased Angle Screw48555448 4.0mm x 48mm Medial Biased Angle Screw48555452 4.0mm x 52mm Medial Biased Angle Screw

Smooth Shank Biased Angle Screws48556322 3.5mm x 22mm Smooth Shank Biased Angle Screw48556324 3.5mm x 24mm Smooth Shank Biased Angle Screw48556326 3.5mm x 26mm Smooth Shank Biased Angle Screw48556328 3.5mm x 28mm Smooth Shank Biased Angle Screw48556330 3.5mm x 30mm Smooth Shank Biased Angle Screw48556332 3.5mm x 32mm Smooth Shank Biased Angle Screw48556334 3.5mm x 34mm Smooth Shank Biased Angle Screw48556336 3.5mm x 36mm Smooth Shank Biased Angle Screw48556338 3.5mm x 38mm Smooth Shank Biased Angle Screw48556340 3.5mm x 40mm Smooth Shank Biased Angle Screw

Cancellous Biased Angle Screws48557310 3.5mm x 10mm Cancellous Biased Angle Screw48557312 3.5mm x 12mm Cancellous Biased Angle Screw48557314 3.5mm x 14mm Cancellous Biased Angle Screw48557316 3.5mm x 16mm Cancellous Biased Angle Screw48557318 3.5mm x 18mm Cancellous Biased Angle Screw48557320 3.5mm x 20mm Cancellous Biased Angle Screw48557322 3.5mm x 22mm Cancellous Biased Angle Screw48557324 3.5mm x 24mm Cancellous Biased Angle Screw

48557410 4.0mm x 10mm Cancellous Biased Angle Screw48557412 4.0mm x 12mm Cancellous Biased Angle Screw48557414 4.0mm x 14mm Cancellous Biased Angle Screw48557416 4.0mm x 16mm Cancellous Biased Angle Screw48557418 4.0mm x 18mm Cancellous Biased Angle Screw48557420 4.0mm x 20mm Cancellous Biased Angle Screw48557422 4.0mm x 22mm Cancellous Biased Angle Screw48557424 4.0mm x 24mm Cancellous Biased Angle Screw

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Part # Description

Non-Biased Angle Polyaxial Screws48558310 3.5mm x 10mm Non-Biased Angle Screw48558312 3.5mm x 12mm Non-Biased Angle Screw48558314 3.5mm x 14mm Non-Biased Angle Screw48558316 3.5mm x 16mm Non-Biased Angle Screw48558318 3.5mm x 18mm Non-Biased Angle Screw48558320 3.5mm x 20mm Non-Biased Angle Screw

48558410 4.0mm x 10mm Non-Biased Angle Screw48558412 4.0mm x 12mm Non-Biased Angle Screw48558414 4.0mm x 14mm Non-Biased Angle Screw48558416 4.0mm x 16mm Non-Biased Angle Screw48558418 4.0mm x 18mm Non-Biased Angle Screw48558420 4.0mm x 20mm Non-Biased Angle Screw

48558520 4.5mm x 20mm Non-Biased Angle Screw48558524 4.5mm x 24mm Non-Biased Angle Screw48558528 4.5mm x 28mm Non-Biased Angle Screw48558532 4.5mm x 32mm Non-Biased Angle Screw48558536 4.5mm x 36mm Non-Biased Angle Screw48558540 4.5mm x 40mm Non-Biased Angle Screw48558544 4.5mm x 44mm Non-Biased Angle Screw48558548 4.5mm x 48mm Non-Biased Angle Screw48558552 4.5mm x 52mm Non-Biased Angle Screw

Rods48553080 3.5mm x 80mm Vitallium Rod48553120 3.5mm x 120mm Vitallium Rod48553240 3.5mm x 240mm Vitallium Rod48553350 3.5mm x 350mm Vitallium Rod

48552025 3.5mm x 25mm Titanium Alloy Rod48552030 3.5mm x 30mm Titanium Alloy Rod48552040 3.5mm x 40mm Titanium Alloy Rod48552050 3.5mm x 50mm Titanium Alloy Rod48552060 3.5mm x 60mm Titanium Alloy Rod48552070 3.5mm x 70mm Titanium Alloy Rod48552080 3.5mm x 80mm Titanium Alloy Rod48552120 3.5mm x 120mm Titanium Alloy Rod48552240 3.5mm x 240mm Titanium Alloy Rod48551240 3.5mm x 240mm Titanium Rod, CP48551350 3.5mm x 350mm Titanium Alloy Rod

Part # Description

Connectors48551070 Transverse Connector, 80mm48551071 Transverse Connector, 60mm48551072 Transverse Connector, 40mm48551073 Cross Connector Plate, 24mm48551074 Cross Connector Plate, 32mm48551075 Cross Connector Plate, 40mm48551080 Offset Connector, 20mm48551081 Offset Connector, 12mm48551085 3.5mm to 3.5mm Axial Connector48551084 3.5mm to 4.5mm Axial Connector48551086 3.5mm to 5.5mm Axial Connector48551087 3.5mm to 6.0mm Axial Connector48551088 3.5mm to 3.5mm Parallel Rod-to-Rod Connector48551091 3.5mm to 4.5mm Parallel Rod-to-Rod Connector48551089 3.5mm to 5.5mm Parallel Rod-to-Rod Connector48551090 3.5mm to 6.0mm Parallel Rod-to-Rod Connector

48551094 Saddle Connector

48551000 Blocker

48551006 Set Screw

Transition Rods48553600 3.5mm-4.5mm Titanium Alloy Transition Rod48553602 3.5mm-4.5mm Vitallium Transition Rod48553604 3.5mm-5.5mm Titanium Alloy Transition Rod48553606 3.5mm-5.5mm Vitallium Transition Rod48553608 3.5mm-6.0mm Titanium Alloy Transition Rod48553610 3.5mm-6.0mm Vitallium Transition Rod

*Special Order Only48553800 3.5mm-4.5mm Titanium Transition Rod 800mm48553804 3.5mm-5.5mm Titanium Transition Rod 800mm48553808 3.5mm-6.0mm Titanium Transition Rod 800mm48553802 3.5mm-4.5mm Vitallium Transition Rod 800mm48553806 3.5mm-5.5mm Vitallium Transition Rod 800mm48553810 3.5mm-6.0mm Vitallium Transition Rod 800mm48553820 3.5mm-4.5mm Titanium Transition Rod 860mm48553824 3.5mm-5.5mm Titanium Transition Rod 860mm48553828 3.5mm-6.0mm Titanium Transition Rod 860mm48553822 3.5mm-4.5mm Vitallium Transition Rod 860mm48553826 3.5mm-5.5mm Vitallium Transition Rod 860mm48553830 3.5mm-6.0mm Vitallium Transition Rod 860mm

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OASYS Surgical TechniquePart # Description

Hooks

48551049 Hook, Standard, 3.5mm

48551050 Hook, Standard Short, 5.0mm

48551053 Hook, Standard, 6.5mm

48551055 Hook, Standard Tall, 8.0mm

48551060 Hook, Offset Right

48551065 Hook, Offset Left

Occiput Fixation48551044 Midline Occiput Plate, Small48551045 Midline Occiput Plate, Medium48551046 Midline Occiput Plate, Large48551047 Midline Occiput Plate, Large Long48551048 Midline Occiput Plate, Mini

48551040 130º Occiput Plate48551041L 130º Pre-contoured Occiput Plate, Left48551041R 130º Pre-contoured Occiput Plate, Right48551042 100º Occiput Plate48551043L 100º Pre-contoured Occiput Plate, Left48551043R 100º Pre-contoured Occiput Plate, Right

Part # Description

Bone Screws48554306 3.5mm x 6mm Bone Screw48554308 3.5mm x 8mm Bone Screw48554310 3.5mm x 10mm Bone Screw48554312 3.5mm x 12mm Bone Screw48554314 3.5mm x 14mm Bone Screw48554316 3.5mm x 16mm Bone Screw

48554406 4.0mm x 6mm Bone Screw48554408 4.0mm x 8mm Bone Screw48554410 4.0mm x 10mm Bone Screw48554412 4.0mm x 12mm Bone Screw48554414 4.0mm x 14mm Bone Screw48554416 4.0mm x 16mm Bone Screw

48554506 4.5 x 6mm Bone Screw48554508 4.5 x 8mm Bone Screw48554510 4.5 x 10mm Bone Screw48554512 4.5 x 12mm Bone Screw48554514 4.5 x 14mm Bone Screw48554516 4.5 x 16mm Bone Screw

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Instruments

Part # Description

Trays

48562000 Standard Implant Container

48562001 Standard Instrument Container

48562002 Auxiliary Instrument Container

48562000H Modular Screw Caddy

48560002 Rod Cutter Tray

48561004 Container 4, Occiput Fixation Tray

Instruments

48560010 Awl

48562010 Awl

48561011 Adjustable Drill Guide

48562011 Adjustable Drill Guide

48561034 Fixed Drill Guide, 12mm

48562034 Fixed Drill Guide, 12mm

48561035 Fixed Drill Guide, 14mm

48562035 Fixed Drill Guide, 14mm

48560012 Quick Release Handle

48562012 Quick Release Handle

Part # Description

48561052 Short Quick Release Handle

48561051 Flexible Shaft

48561056 Straight Shaft

48560323 2.5mm Drill for 3.5mm Screw

48560423 3.0mm Drill for 4.0 & 4.5mm Screws

48565323 2.5mm Drill for 3.5mm Bone Screw

48565423 3.0mm Drill for 4.0mm Bone Screw

48565523 3.5mm Drill for 4.5mm Bone Screw

48561044 Occiput Fixed Drill Guide, 6 & 8mm

48561045 Occiput Fixed Drill Guide, 10 & 12mm

48561046 Occiput Fixed Drill Guide, 14 & 16mm

48561314 3.5mm Tap, 18mm

48561414 4.0mm Tap, 18mm

48560314 3.5mm Tap

48560414 4.0mm Tap

48560514 4.5mm Tap

48561916 3.5mm Cancellous Tap

48561917 4.0mm Cancellous Tap

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OASYS Surgical TechniquePart # Description Part # Description

48561914 Tap Sleeve, 3.5 & 4.0mm

48561915 Tap Sleeve, 4.5mm

48561053 Occiput Set Tap, 3.5mm

48561054 Occiput Set Tap, 4.0mm

48561055 Occiput Set Tap, 4.5mm

48560015 Depth Gauge

48561036 Ball Tip Probe

48561115 Pedicle Probe, 3.5mm

48562115 Pedicle Probe, 4.5mm

48562118 Pedicle Probe

48562016 Polyaxial Screwdriver

48562018 Polyaxial Screwdriver

48563016 Polyaxial Screwdriver, Locking

48562037 Poly Adjustment Driver

48561043 Angled Driver

48561050 Short Driver

48560017 Rod Template

48560030 Bilateral Occiput Plate Bend Template

48560018 Rod/Plate Cutter

48561038 Small Rod Cutter

48560019 Rod/Plate Bender

48562100 Rod/Blocker Inserter

48560020 Rod Forceps

48561039 Rod Rotation Forceps

48560021 Screw Head Adjuster

48560022 In-situ Bender, Right

48560023 In-situ Bender, Left

48561049 Occiput Plate Bending Irons (2)

48562024 Corkscrew Persuader

48561024 Locking Persuader

48560024 Persuader

48561042 Hexdriver

48561026 Compressor

48561041 Distractor

48560027 Insertion Tube/Anti-torque Key

48562027 Insertion Tube/Anti-torque Key

48560028 Torque Wrench

48562028 Torque Wrench

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48561028 Audible Torque Wrench

48560029 Connector Clip Inserter

48560129 Connector Clip Remover

48561071 Connector Plate Bender

48561073 Locking Nut Socket, Connector Plate

48561074 Cross Connector Nut Inserter

48561075 Cross Connector Nut Tightener

48510300 Plate Holder

48560032 Hook Preparer

48560033 Hook Forceps

Part # Description

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OASYS Surgical TechniqueSTRYKER SPINE OASYS SYSTEM

DESCRIPTIONThe STRYKER Spine OASYS System isintended for use as an aid in spine fusion. Itconsists of screws, hooks, plates, rods andconnectors. These components are availablein a variety of lengths in order toaccommodate individual patient physiologyand pathology and to facilitate posteriorstabilization of the spine.

INDICATIONSThe Stryker Spine OASYS System is intendedto provide immobilization and stabilizationof spinal segments as an adjunct to fusionfor the following acute and chronicinstabilities of the craniocervical junction,the cervical spine (C1 to C7) and thethoracic spine (T1-T3): traumatic spinalfractures and/or traumatic dislocations;instability or deformity; failed previousfusions (e.g. pseudoarthrosis); tumorsinvolving the cervical/thoracic spine; anddegenerative disease, including intractableradiculopathy and/or myelopathy, neckand/or arm pain of discogenic origin asconfirmed by radiographic studies, anddegenerative disease of the facets withinstability.

The Stryker Spine OASYS System is alsointended to restore the integrity of the spinalcolumn even in the absence of fusion for alimited time period in patients withadvanced stage tumors involving the cervicalspine in whom life expectancy is ofinsufficient duration to permit achievementof fusion.

The Stryker Spine OASYS System can belinked to the XIA System, SR90D System andXIA 4.5 Spinal System via the rod-to-rodconnectors and transition rods.

The Stryker Spine OASYS System can also belinked to the polyaxial screws of the XIA IIand XIA 3 Systems via the saddle connector.

CONTRAINDICATIONSContraindications may be relative orabsolute. The choice of a particular devicemust be carefully weighed against thepatient’s overall evaluation. Circumstanceslisted below may reduce the chances of asuccessful outcome:• Any abnormality present, which affects thenormal process of bone remodelingincluding, but not limited to, severeosteoporosis involving the spine, boneabsorption, osteopenia, active infection atthe site or certain metabolic disordersaffecting osteogenesis.

• Insufficient quality or quantity of bone,which would inhibit rigid device fixation.

• Previous history of infection.• Excessive local inflammation.• Open wounds.• Obesity. An overweight or obese patient canproduce loads on the spinal system, whichcan lead to failure of the fixation of thedevice or to failure of the device itself.

• Patients having inadequate tissue coverageof the operative site.

• Pregnancy• A condition of senility, mental illness, orsubstance abuse. These conditions, amongothers, may cause the patient to ignorecertain necessary limitations andprecautions in the use of the implant,leading to failure or other complications.

• Foreign body sensitivity. Where materialsensitivity is suspected, appropriate testsshould be made prior to material selectionor implantation.

• Other medical or surgical condition whichwould preclude the potential benefit ofspinal implant surgery, such as the presenceof, congenital abnormalities, elevation ofsedimentation rate unexplained by otherdiseases, elevation of white blood cell count(WBC), or marked left shift in the WBCdifferential count.

These contraindications can be relative orabsolute and must be taken into account bythe physician when making his decision. Theabove list is not exhaustive.

INFORMATION FOR THE PATIENTThe surgeon must discuss all physical andpsychological limitations inherent to the useof the device with the patient. This includesthe rehabilitation regimen, physical therapy,and wearing an appropriate orthosis asprescribed by the physician. Particulardiscussion must be directed to the issues ofpremature weightbearing, activity levels, andthe necessity for periodic medical follow-up.

The surgeon must warn the patient of thesurgical risks and make the patient aware ofpossible adverse effects. The surgeon mustwarn the patient that the device cannot anddoes not replicate the flexibility, strength,reliability or durability of normal healthybone, that the implant can break or becomedamaged as a result of strenuous activity ortrauma, and that the device may need to bereplaced in the future. If the patient isinvolved in an occupation or activity whichapplies inordinate stress upon the implant(e.g., substantial walking, running, lifting, ormuscle strain) the surgeon must advise the

patient that resultant forces can cause failureof the device. Patients who smoke have beenshown to have an increased incidence ofnon-unions. Surgeons must advise patientsof this fact and warn of the potentialconsequences. For patients with degenerativedisease, the progression of degenerativedisease may be so advanced at the time ofimplantation that it may substantiallydecrease the expected useful life of theappliance. In such cases, orthopaedic devicesmay be considered only as a delayingtechnique or to provide temporary relief.

ADVERSE EFFECTSWhile the expected life of spinal implantcomponents is difficult to estimate, it isfinite. These components are made offoreign materials, which are placed withinthe body for the potential fusion of the spineand reduction of pain. However, due to themany biological, mechanical andphysicochemical factors, which affect thesedevices but cannot be evaluated in vivo, thecomponents cannot be expected toindefinitely withstand the activity level andloads of normal healthy bone. The followinglist is representative, though not all inclusive,of the potentially adverse effects that thesurgeon must consider whenever implantinga spinal fixation system or device:• Bending, disassembly or fracture of any orall implant components.

• Fatigue fracture of spinal fixation devices,including screws, rods, and hooks hasoccurred.

• Pain, discomfort, or abnormal sensationsdue to the presence of the device.

• Pressure on skin from components whereinadequate tissue coverage exists over theimplant, with the potential extrusionthrough the skin.

• Dural leak requiring surgical repair. Thisrisk is related to the surgical procedure.The intended use of the device does notrequire it to be close to the dura.

• Cessation of growth of the fused portion ofthe spine.

• Loss of proper spinal curvature, correction,height and/or reduction.

• Delayed Union or Nonunion: Internalfixation appliances are load sharing deviceswhich are used to obtain alignment untilnormal healing occurs. In the event thathealing is delayed, does not occur, orfailure to immobilize thedelayed/nonunion results, the implant willbe subject to excessive and repeated stresseswhich can eventually cause loosening,bending or fatigue fracture. The degree orsuccess of union, loads produced by weight

NON STERILE PRODUCT

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bearing, and activity levels will, amongother conditions, dictate the longevity ofthe implant. If a nonunion develops or ifthe implants loosen, bend or break, thedevice(s) must be revised or removedimmediately before serious injury occurs.

• Loosening of spinal fixation implants canoccur. Early mechanical loosening mayresult from inadequate initial fixation, latentinfection, premature loading of theprosthesis or trauma. Late loosening mayresult from trauma, infection, biologicalcomplications or mechanical problems,with the subsequent possibility of boneerosion, migration and/or pain.

• Cervical spine procedures may be associatedwith vascular and neural complicationssuch as arterial injury or mechanicalcompromise, cord contusion and damage,peripheral nerve compromise and damage,including but not limited to peripheralparalysis, sensory disorders, vasculardisorders, loss or disturbance of bladderand bowel functions.

• Serious complications may be associatedwith any surgery. These complicationsinclude, but are not limited to:genitourinary disorders; gastrointestinaldisorders; vascular disorders, includingthrombus; bronchopulmonary disorders,including emboli; bursitis, hemorrhage,myocardial infarction, infection, paralysis ordeath.

• Neurological, vascular, or soft tissue damagedue directly to the unstable nature of thefracture, or to surgical trauma.

• Inappropriate or improper surgicalplacement of this device may causedistraction or stress shielding of the graft orfusion mass. This may contribute to failureof an adequate fusion mass to form.

• Decrease in bone density due to stressshielding.

• Intraoperative fissure, fracture, orperforation of the spine can occur due toimplantation of the components.Postoperative fracture of bone graft, theintervertebral body, pedicle, and/or lateralmass above and/or below the level ofsurgery can occur due to trauma, thepresence of defects, or poor bone stock.

• Adverse effects may necessitate reoperationor revision.

The surgeon must warn the patient of theseadverse effects as deemed necessary.

REMOVAL OF IMPLANTSThese implants are temporary internalfixation devices designed to stabilize theoperative site during the normal healing

process. After healing occurs, these devicesserve no functional purpose and can beremoved. Removal may also berecommended in other cases, such as:• Corrosion with a painful reaction.• Migration of the implant, with subsequentpain and/or neurological, articular or softtissue lesions.

• Pain or abnormal sensations due to thepresence of the implants.

• Infection or inflammatory reactions.• Reduction in bone density due to thedifferent distribution of mechanical andphysiological stresses and strains.

• Bone growth restraint due to the presenceof the implants.

• Failure or mobilization of the implant.

Instruments are provided by STRYKERSpine to be used to remove the implants. Anydecision by a physician to remove theinternal fixation device must take intoconsideration such factors as the risk to thepatient of the additional surgical procedureas well as the difficulty of removal. Removalof an unloosened spinal screw may requirethe use of special instruments to disrupt theinterface at the implant surface. Thistechnique may require practice in thelaboratory before being attempted clinically.Implant removal must be followed byadequate postoperative management to avoidfracture or re-fracture. Removal of theimplant after fracture healing isrecommended. Metallic implants can loosen,bend, fracture, corrode, migrate, cause painor stress shield bone.

PREOPERATIVE PRECAUTIONSSurgical Technique brochures may be byrequested from a distributor or fromSTRYKER Spine directly. Those usingbrochures published more than two yearsbefore the surgical intervention are advisedto obtain an updated version.

STRYKER Spine devices can only be used bydoctors who are fully familiar with thesurgical technique required and who havebeen trained to this end. The doctoroperating must take care not to use theinstruments to exert inappropriate stress onthe spine or the implants and mustscrupulously comply with any operatingprocedure described in the surgicaltechnique provided by STRYKER Spine. Forexample, the forces exerted whenrepositioning an instrument in-situ must notbe excessive as this is likely to cause injury tothe patient.

To reduce the risks of breakage, care must betaken not to distort the implants or nick, hitor score them with the instruments unlessotherwise specified by the applicableSTRYKER Spine Surgical Technique.

Extreme care must be taken when theinstruments are used near vital organs,nerves or vessels.

Unless otherwise specified on the label, theinstruments may be reused afterdecontamination, cleaning and sterilization.

WARNINGSFederal law restricts this device to sale by oron the order of a licensed physician.

The safety and effectiveness of pedicle screwspinal systems have been established only forspinal conditions with significant mechanicalinstability requiring fusion withinstrumentation. These conditions aresignificant mechanical instability of thethoracic, lumbar, and sacral spine secondaryto degenerative spondylolisthesis withobjective evidence of neurologicalimpairment, fracture, dislocation, spinaltumor, and failed previous fusion(pseudoarthrosis). The safety andeffectiveness of these devices for any otherconditions are unknown.

PRECAUTIONSThe implantation of pedicle screw spinalsystems must be performed only byexperienced spinal surgeons with specifictraining in the use of this pedicle screw spinalsystem because this is a technicallydemanding procedure presenting a risk ofserious injury to the patient.

Based on the fatigue testing results, thephysician/surgeon must consider the levels ofimplantation, patient weight, patient activitylevel, other patient conditions, etc., whichmay impact on the performance of thesystem.

The STRYKER Spine OASYS System has notbeen evaluated for safety and compatibility inthe MR environment. STRYKER SpineOASYS System has not been tested forheating or migration in the MRenvironment.

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Stryker Spine2 Pearl Court Allendale, NJ 07401-1677 USAt: 201-760-8000www.stryker.com

A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use aparticular product when treating a particular patient. Stryker does not dispense medical advice and recommendsthat surgeons be trained in the use of any particular product before using it in surgery.

The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon mustalways refer to the package insert, product label and/or instructions for use before using any Stryker product.Products may not be available in all markets because product availability is subject to the regulatory and/or medicalpractices in individual markets. Please contact your Stryker representative if you have questions about theavailability of Stryker products in your area.

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the followingtrademarks or service marks: OASYS, SR90D, Stryker, Vitallium, Xia. All other trademarks are trademarks of theirrespective owners or holders.

CVOAS-ST-6_Rev-3SC/GS 01/16

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