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Distal Anterolateral TibiaDistal Medial Tibia

Operative Technique

AxSOS Locking Plate System

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This publication sets forth detailedrecommended procedures for usingStryker Osteosynthesis devices andinstruments.

It offers guidance that you shouldheed, but, as with any such technicalguide, each surgeon must consider

the particular needs of each patientand make appropriate adjustmentswhen and as required.

A workshop training is required priorto first surgery.

See package insert (V15011, V15013and V15034) for a complete list ofpotential adverse effects,contraindications, warnings andprecautions. The surgeon must discussall relevant risks, including the finitelifetime of the device, with the patient,when necessary.

Warning:

All bone screws referenced in this document here are not approved for screw attachment or fixation tothe posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Contents

Page

1. Introduction 3

2. Features & Benefits 4

3. Relative Indications & Contraindictions 5

Relative Indications 5

Relative Contraindications 5

4. Operative Technique 6

General Guidelines 6

Steps 8

Step 1 - Pre-operative Planning 8

Step 2a - Pre-Operative Locking Insert Application 8

Step 2b -Intra-Operative Locking Insert Application 9

Step 3 - Aiming block /Plate Insertion Handle Assembly 9

Step 4 - Plate Application 10

Step 5 - Primary Plate Fixation - Distal 10

Step 6 - Primary Plate Fixation - Proximal (Optional) 11

Step 7 - Metaphyseal Locking 11

Step 8 - Shaft Fixation 13

Step 9 - Kick Stand Screw Placement 14

5. Additional Tips 15

Sub Muscular Insertion Technique 16

Ordering Information - Implants 18

Ordering Information - 4.0mm Instruments 20

Additional Information 22

Introduction

The AxSOS Locking Plate System is designed to treat periarticular or intra-articular fractures of theProximal Humerus, Distal Femur,Proximal Tibia and the Distal Tibia.The system design is based on clinicalinput from an international panel ofexperienced surgeons, data fromliterature, and both practical andbiomechanical testing. The anatomicalshape, the fixed screw trajectory, andhigh surface quality take into accountthe current demands of clinicalphysicians for appropriate fixation,high fatigue strength, and minimal soft tissue damage. This OperativeTechnique contains a simple step-by-step procedure for theimplantation of the the anterolateraland medial distal Tibial Plates.

Distal Medial Tibial Plate

Distal Anterolateral Tibial Plate

Distal Lateral Femoral Plate

Proximal Lateral Tibial Plate

Proximal Humeral Plate

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Aiming Blocks

• Facilitates the placement of the Drill Sleeve.

Features & Benefits

System

• The anterolateral and the medialdistal Tibial Plates are designed with optimised fixed-angeled screwtrajectories which provide increasedbiomechanical stability. This helpsprevent loss of reduction.

Instruments

• Simple technique, easyinstrumentation with minimalcomponents.

• Compatible with MIPO (MinimallyInvasive Plate Osteosynthesis)technique using state of the artinstrumentation.

Range

• Longer plates cover a wider range of fractures.

Unthreaded Freedom Holes

• Freehand placement of screws.

• Lag Screw possibility.

Rounded & Tapered Plate End

• Helps facilitate sliding of plates sub-muscularly.

K-Wire/Reduction/Suture holes

• Primary/temporary plate and fracture fixation.

Anatomically contoured

• Little or no bending required.

• Reduced OR time.

Kick-Stand Screw

• Aimed at medial/lateral fragment toprovide strong triangular fixation.

Shaft Holes - Standard or Locking

• Bi-directional shaft holes.

• Compression, neutral or buttress fixation.

• Accepts Standard 3.5/4.0mm SPS screws.

• Accepts Locking Insert for axiallystable screws.

Monoaxial holes (4)

• Allows axially stable screw placement,bringing stability to construct.

‘Waisted’ plate shape

• Uniform load transfer.

Monoaxial holes (3)

• Allows axially stable screw placement,bringing stability to construct.

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Innovative Locking Screw design

• The single thread screw design allowseasy insertion into the plate, reducingany potential for cross threading orcold welding.

Relative Indications & Contraindications

Relative Indications

• Patients having inadequate tissuecoverage over the operative site.

• Implant utilisation that wouldinterfere with anatomical structuresor physiological performance.

• Any mental or neuromusculardisorder which would create anunacceptable risk of fixation failureor complications in postoperativecare.

• Other medical or surgical conditionswhich would preclude the potentialbenefit of surgery.

Detailed information is included in theinstructions for use being attached toevery implant.

See package insert for a complete list of potential adverse effects andcontraindications. The surgeon mustdiscuss all relevant risks, including thefinite lifetime of the device, with thepatient, when necessary.

Caution:Bone Screws are not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

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The physician's education, training andprofessional judgement must be reliedupon to choose the most appropriatedevice and treatment. The followingcontraindications may be of a relativeor absolute nature, and must be takeninto account by the attending surgeon:

• Any active or suspected latentinfection or marked localinflammation in or about the affected area.

• Compromised vascularity that wouldinhibit adequate blood supply to thefracture or the operative site.

• Bone stock compromised by disease,infection or prior implantation thatcan not provide adequate supportand/or fixation of the devices.

• Material sensitivity, documented or suspected.

• Obesity. An overweight or obesepatient can produce loads on theimplant that can lead to failure of the fixation of the device or to failure of the device itself.

The indication for use of these internalfixation devices includes metaphysealextra and intra-articular fractures ofthe distal Tibia.

Relative Contraindications

Operative Technique

Patient Positioning: Supine

Surgical Approach Lateral: Between lateral Tibia and Fibula

Surgical Approach Medial: Distal oblique 1cm proximal to the

medial Malleolus

Instrument/Screw Set: 4.0mm

Reduction

Anatomical reduction of the fractureshould be performed either by directvisualisation with the help ofpercutaneous clamps and/or K-Wiresor alternatively a bridging externalFixator can aid indirect reduction.Fracture reduction of the articularsurface should be confirmed by directvision, or fluoroscopy. Use K-Wires asnecessary to temporarily secure thereduction.

Typically, K-Wires set parallel to thejoint axis will not only act to hold andsupport the reduction, but also help tovisualise/identify the joint. Care must betaken that these do not interfere withthe required plate and screw positions.

Consideration must also be taken whenpositioning independent Lag Screwsprior to plate placement to ensure thatthey do not interfere with the plannedplate location or Locking Screwtrajectories.

If any large bony defects are presentthey should be filled by either bonegraft or bone substitute material.

Note: If a sub-muscular technique hasbeen used please see the relevantsection later in this Guide.

Bending

In most cases the pre-contoured platewill fit without the need for furtherbending. However, should additionalbending of the plate be required(generally at the junction from themetaphysis to the shaft) the BendingIrons (REF 702756) should be used.Bending of the plate in the region ofthe metaphyseal locking holes willaffect the ability to correctly seat theLocking Screws into the plate and istherefore not permitted.

Plate contouring in the shaft regionshould be restricted to the area betweenthe shaft holes. Plate contouring willaffect the ability to place a LockingInsert into the shaft holes adjacent tothe bending point.

General Guidelines

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Operative Technique

Measurement Options

Conventional Direct

Measure off K-Wire Read off Calibration

Measure off Drill

General Guidelines

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Locking Screw Measurement

There are four options to obtain theproper Locking Screw length asillustrated below.

Correct Screw Selection

Select a screw approximatley 2-3mmshorter than the measured length toavoid screw penetrations through theopposite cortex in metaphysealfixation.

Add 2-3mm to measured length foroptimal bi-cortical shaft fixation.

StepsStep 1 – Pre-Operative Planning

Use of the X-Ray Template (REF 981093 for lateral or 981092 for medial) or Plate Trial (REF 702797 for lateral or REF 702795 for medialrespectively) in association withfluoroscopy can assist in the selection ofan appropriately sized implant. (Fig 1).

If the Plate Trial is more than 90mmaway from the bone, e.g. with obesepatients, a magnification factor of 10-15% will occur and must becompensated for. Final intraoperativeverification should be made to ensurecorrect implant selection.

Operative Technique

Fig. 1

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Step 2a – Pre-Operative Locking Insert Application

If Locking Screws are chosen for theplate shaft, pre-operative insertion of Locking Inserts is recommended.

A 4.0mm Locking Insert (REF 370002)is attached to the Locking Insert Inserter(REF 702762) and placed into thechosen holes in the shaft portion of theplate (Fig. 2). Ensure that the LockingInsert is properly placed. The Insertershould then be removed (Fig. 2a).

Note:Do not place Locking Inserts with the Drill Sleeve.

It is important to note that if aTemporary Plate Holder is to be usedfor primary distal plate fixation, then aLocking Insert must not be placed inthe same hole as the Temporary PlateHolder (See Step 6).

Fig. 2

Fig. 2a

Fig. 1a

Locking Insert Extraction

Should removal of a Locking Insert be required for any reason, then thefollowing procedure should be used.Thread the central portion (A) of theLocking Insert Extractor (REF 702767)into the Locking Insert that you wishto remove until it is fully seated (Fig. 2b).

Then turn the outer sleeve/collet (B)clockwise until it pulls the LockingInsert out of the plate (Fig. 2c). The Locking Insert must then bediscarded, as it cannot be reused.

Fig. 2c

B

A

Fig. 2b

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Step 3 – Aiming Block/Plate Insertion Handle Assembly

Screw the appropriate Aiming Block(REF 702723/702722 for lateral or702725/702724 for medial respectively)to the plate using the Screwdriver T15(REF 702747). If desired, the Handlefor Plate Insertion (REF 702778) cannow be attached to help facilitate platepositioning and sliding of longer platessub-muscularly. (Fig 3)

Step 2b – Intra – Operative Locking Insert Application

If desired, a Locking Insert can beapplied in a compression hole in theshaft of the plate intra-operatively byusing the Locking Insert Forceps (REF 702968), Centering Pin (REF 702673), Adaptor for Centering Pin(REF 702675), and Guide for CenteringPin (REF 702671).

First, the Centering Pin is insertedthrough the chosen hole using theAdaptor and Guide (Fig. 2d). It isimportant to use the Guide as thiscenters the core hole for Locking Screwinsertion after the Locking Insert isapplied. After inserting the Centering Pinbi-cortically, remove the Adaptor andGuide.

Next, place a Locking Insert on the endof the Forceps and slide the instrumentover the Centering Pin down to the hole(Fig. 2e).

Last, apply the Locking Insert bytriggering the forceps handle. Push the button on the Forceps to remove the device (Fig. 2f). At thistime, remove the Centering Pin.

Fig. 2d

Fig. 2e Fig. 2f

Operative Technique

Fig. 3

Step 5 – Primary Plate Fixation –Distal

The K-Wire holes in the plates allowtemporary plate fixation in themetaphysis and the shaft part.

Using the K-Wire Sleeve (REF 702702)in conjunction with the Drill Sleeve(REF 702707), a 2.0x230mm K-Wirecan now be inserted into one of thedistal Locking Screw holes (Fig. 5).This step shows the position of thescrew in relation to the joint surfaceand confirms the screw will not beintra articular.

Using fluoroscopy, the position of this K-Wire can be checked until theoptimal position is achieved and theplate is correctly positioned. Correct proximal placement shouldalso be reconfirmed at this point tomake sure the plate shaft is properlyaligned over the lateral respectively themedial surface of the Tibial shaft(Fig. 6). Secure the position byinserting a K-Wire in the hole above the Kick-Stand Screw hole.

If the distal and axial alignment of theplate cannot be acheived, the K-Wiresshould be removed, the platereadjusted, and the above procedurerepeated until both the distal K-Wireand the plate are in the desiredposition.

Do not remove the Drill Sleeve and K-Wire Sleeve at this point as it willcause a loss of the plate position.

Remove the Handle for Insertion bypressing the metal button at the end of the Handle.

Fig. 7

Step 4 – Plate Application

After skin incision and anatomicalreduction is achieved, apply andmanipulate the plate until optimalposition in relation to the joint isachieved. (approx. 5mm above theanterior articular surface).

This helps to ensure that the mostdistal Locking Screws are directlysupporting the joint surface. (Fig. 4)

Operative Technique

Fig. 4 – Lateral View

Fig. 6 Fig. 5

Fig. 4 – Medial View

Additional K-Wires can be inserted inthe K-Wire holes distal to the lockingholes to further help secure the plate to the bone and also support depressedareas in the articular surface.

Using a 2.5mm Drill (REF 700347-125mm or REF 700355-230mm) andDouble Drill Guide (REF 702418), drill a core hole to the appropriatedepth in the shaft hole above the most proximal fracture line.

The length is then measured using the Depth Gauge for Standard Screws(REF 702879) and an appropriate Self-Tapping 3.5mm Cortical Screw or a 4.0mm Cancellous Screw is then inserted using Screwdriver (REF 702841) (Fig. 7).

If inserting a cancellous screw, the nearcortex must be pre-tapped using theTap (REF 702805) and the TeardropHandle (REF 702428).

Any K-Wires in the shaft can now beremoved.

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Step 6 – Primary Plate Fixation –Proximal (Optional)

The proximal end of the plate can now be secured. This can be achievedthrough one of four methods:

• A K-Wire inserted in the proximalshaft K-Wire hole.

• A 3.5mm Cortical or 4.0mmCancellous Screw using the standardtechnique.

• A 4.0mm Locking Screw with a Locking Insert (see Step 8 – Shaft Locking).

• The Temporary Plate Holder (REF 702776).

In addition to providing temporaryfixation, this device pushes the plate to the bone. Also, it has a self drilling,self tapping tip for quick insertion intocortical bone.

To help prevent thermal necrosis duringthe drilling stage, it is recommendedthat this device is inserted by hand.Once the device has been insertedthrough the far cortex, the threadedouter sleeve/collet is turned clockwiseuntil the plate is in contact with thebone (Fig. 8).

The core diameter of this instrument is 2.4mm to allow a 3.5mm CorticalScrew to be subsequently inserted in the same plate hole.

Note:

A Locking Insert and Locking Screw should not be used in the hole where the Temporary Plate Holder is used.

Step 7 – Metaphyseal Locking

Locking Screws cannot act as Lag Screws. Should an interfragmentarycompression effect be required, a 4.0mm Standard Cancellous Screw ora 3.5mm Standard Cortex Screw mustfirst be placed in the unthreadedmetaphyseal plate holes (Fig. 9) priorto the placement of any LockingScrews. Measure the length of thescrew using the Depth Gauge forStandard Screws (REF 702879), and pre-tap the near cortex with the Tap (REF 702805)if a CancellousScrew is used.Consideration must also be takenwhen positioning this screw to ensurethat it does not interfere with the givenLocking Screw trajectories. (Fig 10).

Operative Technique

Fig. 9

Fig. 10

Fig. 8

Fig. 11

Fig. 13

Operative Technique

The Drill Sleeve should now beremoved, and the correct length4.0mm Locking Screw is inserted usingthe Screwdriver T15 (REF 702747) andScrew Holding Sleeve (REF 702732)(Fig. 12). Locking Screws shouldinitially be inserted manually to ensureproper alignment.

If the Locking Screw thread does notengage immediately in the platethread, reverse the screw a few turnsand re-insert the screw once it isproperly aligned.

Fig. 12

Fixation of the metaphyseal portion ofthe plate can be started using the presetK-Wire in one of the distal lockinghole as described in Step 5. The length of the screw can be takenby using the K-Wire side of the Drill/K-Wire Depth Gauge (REF 702712).(See Locking Screw MeasurementGuidelines on Page 7).

Remove the K-Wire and K-Wire Sleeve leaving the Drill Sleeve in place. A 3.1mm Drill (REF 702742) is thenused to drill the core hole for theLocking Screw (Fig. 11).Using Fluoroscopy, check the correctdepth of the drill, and measure thelength of the screw.

Final tightening of Locking Screwsshould always be performed manuallyusing the Torque Limiting Attachment(REF 702750) together with the SolidScrewdriver T15 (REF 702753) and T-Handle (REF 702427).

This helps to prevent over-tighteningof Locking Screws, and also ensuresthat these Screws are tightened to amaximum torque of 4.0Nm. The device will click when the torquereaches 4Nm (Fig. 13).

If inserting Locking Screws underpower, make sure to use a low speed to avoid damage to the screw/plateinterface, and perform final tighteningby hand. The remaining distal LockingScrews are inserted following the sametechnique with or without the use of a K-Wire.

Always use the Drill Sleeve (REF 702707) when drilling for locking holes.

To ensure maximum stability, it isrecommended that all locking holes are filled with a Locking Screw of theappropriate length.

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Note:

Ensure that the screwdriver tip is fully seated in the screw head, but do not apply axial force during final tightening

Note: The Torque Limiters require routine maintenance. Refer to the Instructions for Maintenance of Torque Limiters (REF V15020)

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Operative Technique

Option 2 – Locking Screws

4.0mm Locking Screws can be placedin a shaft hole provided there is a pre-placed Locking Insert in the hole.(See Step 2a).

The Drill Sleeve(REF 702707) is threaded into the Locking Insert toensure initial fixation of the LockingInsert into the plate. This will alsofacilitate subsequent screw placement.A 3.1mm Drill Bit (REF 702742) is used to drill through both cortices(Fig. 15).

Avoid any angulation or excessive forceon the drill, as this could dislodge theLocking Insert. The screw measurementis then taken.

The appropriate sized Locking Screw is then inserted using the ScrewdriverT15 (REF 702753) and the ScrewHolding Sleeve (REF 702732) togetherwith the Torque Limiting Attachment(REF 702750) and the T-Handle (REF 702427).

Note: Ensure that the screwdriver tip is fully seated in the screw head, but do not apply axial force during final tightening

Maximum stability of the LockingInsert is achieved once the screw isfully seated and tightened to 4.0Nm.

This procedure is repeated for all holeschosen for locked shaft fixation.

All provisional plate fixation devices (K-Wires, Temporary Plate Holder, etc.)can now be removed.

Option 1 – Standard Screws

3.5mm Standard Cortical Screws canbe placed in Neutral, Compression orButtress positions as desired using the relevant Drill Guides and thestandard technique.

These screws can also act as lag screws.

Step 8 – Shaft Fixation

The shaft holes of this plate have been designed to accept either 3.5mmStandard Cortical Screws or 4.0mmLocking Screws together with thecorresponding Locking Inserts.

If a combination of Standard andLocking Screws is used in the shaft,then the Standard Cortical Screwsmust be placed prior to the Locking Screws. (Fig. 14)

Buttress

Compression

Neutral Drill Sleeve Handle

14º TransverseAngulation70º Axial AngulationLocked Hole

Fig. 15

Fig. 14

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Operative Technique

Step 9 – Kick-Stand ScrewPlacement

The oblique ‘Kick-Stand’ LockingScrew provides strong triangularfixation to the opposite fragments. It is advised that this screw is placedwith the assistance of fluoroscopy toprevent joint penetration andimpingement with the distal Screws(Fig. 16). (See Step 7 for insertion guidelines)The Aiming Block should now be removed.

Fig. 16

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Additional Tips

1. Always use the threaded Drill Sleevewhen drilling for Locking Screws(threaded plate hole or LockingInsert).

Free hand drilling will lead to amisalignment of the Screw andtherefore result in screw jammingduring insertion. It is essential, to drillthe core hole in the correct trajectoryto facilitate accurate insertion of theLocking Screws.

If the Locking Screw thread does notimmediately engage the plate thread,reverse the screw a few turns and re-insert the screw once it is properlyaligned.

2. Always start inserting the screwmanually to ensure properalignment in the plate thread andthe core hole.It is recommended to start insertingthe screw using “the two fingertechnique” on the Teardrop handle.Avoid any angulations or excessiveforce on the screwdriver, as thiscould cross-thread the screw.

Power can negatively affect Screwinsertion, if used improperly, damaging the screw/plate interface(screw jamming). This can lead toscrew heads breaking or being stripped.

Again, if the Locking Screw does notadvance, reverse the screw a few turns,and realign it before you start re-insertion.

3. If power insertion is selected aftermanual start (see above), use lowspeed only, do not apply axialpressure, and never “push” thescrew through the plate!

Allow the single, continuousthreaded screw design to engage theplate and cut the thread in the boneon its own, as designed.

Stop power insertion approximately1cm before engaging the screw headin the plate.

4. It is advisable to tap hard (dense)cortical bone before inserting aLocking Screw.

5. Do not use power for finalinsertion of Locking Screws. It isimperative to engage the screw headinto the plate using the TorqueLimiting Attachment. Ensure thatthe screwdriver tip is fully seated inthe screw head, but do not applyaxial force during final tightening.

If the screw stops short of finalposition, back up a few turns andadvance the screw again (withtorque limiter on).

The spherical tip of the Tap preciselyaligns the instrument in the predrilledcore hole during thread cutting. This will facilitate subsequent screwplacement.

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The Standard Percutaneous Drill Sleeve(REF. 702709) or Neutral PercutaneousDrill Sleeve (REF 702957) inconjunction with the Drill SleeveHandle (REF 702822) can be used toassist with drilling for Standard Screws.Use a 2.5mm Drill Bit (REF 700355).

With the aid of the Soft TissueSpreader (REF 702919), the skin can be opened to form a small window (Fig. 20-21) through which either a Standard Screw or Locking Screw(provided a Locking Insert is present)can be placed. For Locking Screwinsertion, use the threaded Drill Guide(REF 702707) together with the 3.1mm Drill Bit (REF 702742) to drill the core hole.

Sub-Muscular Insertion Technique

When implanting longer plates, a minimally invasive technique can be used. The Soft Tissue Elevator (REF 702782) can be used to create apathway for the implant (Fig. 17). The plate has a special rounded andtapered end, which allows a smoothinsertion under the soft tissue (Fig. 18).

Additionally, the Shaft Hole Locatorcan be used to help locate the shaftholes. Attach the appropriate side ofthe Shaft Hole Locator (REF 702797for lateral or 702795 for medialrespectively) by sliding it over the topof the Handle until it seats in one ofthe grooves at a appropriate distanceabove the skin.

The slot and markings on the HoleLocator act as a guide to the respectiveholes in the plate. A small stab incisioncan then be made through the slot tolocate the hole selected for screwplacement (Fig. 19). The Trial can then be rotated out of the way or removed.

Fig. 18

Fig. 19

Fig. 21Fig. 20

Operative Technique

Fig. 17

Fig. 23 Fig. 24Fig. 22

Fig. 26Fig. 25 Fig. 27

Operative Technique

Final plate and screw positions areshown in Figures 22-27.

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Ordering Information - Implants

Stainless Steel SystemREF mm

370002 4.0

4.0MM LOCKING INSERT

Stainless Steel Plate Shaft LockingREF Length Holes Holes

Left Right mm

436404 436424 97 4 3436406 436426 123 6 3436408 436428 149 8 3436410 436430 175 10 3436412 436432 201 12 3436414 436434 227 14 3436416 436436 253 16 3

DISTAL ANTEROLATERAL TIBIA Locking Screws Ø4.0mm Standard Screws Ø3.5, 4.0mm

Stainless Steel Plate Shaft LockingREF Length Holes Holes

Left Right mm

436204 436224 94 4 4436206 436226 120 6 4436208 436228 146 8 4436210 436230 172 10 4436212 436232 198 12 4436214 436234 224 14 4436216 436236 250 16 4

DISTAL MEDIAL TIBIA Locking Screws Ø4.0mm Standard Screws Ø3.5, 4.0mm

Note: For Sterile Implants, add ‘S’ to REF

Stainless ScrewSteel LengthREF mm

371514 14371516 16371518 18371520 20371522 22371524 24371526 26371528 28371530 30371532 32371534 34371536 36371538 38371540 40371542 42371544 44371546 46371548 48371550 50371555 55371560 60371565 65371570 70371575 75371580 80371585 85371590 90371595 95

Stainless ScrewSteel LengthREF mm

345514 14345516 16345518 18345520 20345522 22345524 24345526 26345528 28345530 30345532 32345534 34345536 36345538 38345540 40345545 45345550 50345555 55345560 60345565 65345570 70345575 75345580 80345585 85345590 90345595 95

Stainless ScrewSteel Length REF mm

338614 14338616 16338618 18338620 20338622 22338624 24338626 26338628 28338630 30338632 32338634 34338636 36338638 38338640 40338642 42338644 44338646 46338648 48338650 50338655 55338660 60338665 65338670 70338675 75338680 80338685 85338690 90338695 95

Stainless ScrewSteel Length REF mm

345414 14345416 16345418 18345420 20345422 22345424 24345426 26345428 28345430 30345432 32345434 34345436 36345438 38345440 40345445 45345450 50345455 55345460 60345465 65345470 70345475 75345480 80345485 85345490 90345495 95

4.0MM LOCKING SCREW, SELF TAPPING T15 DRIVE

3.5MM CORTICAL SCREW, SELF TAPPING2.5MM HEX DRIVE

Ordering Information - Implants

4.0MM CANCELLOUS SCREW, PARTIAL THREAD 2.5MM HEX DRIVE

4.0MM CANCELLOUS SCREW, FULL THREAD2.5MM HEX DRIVE

Note: For Sterile Implants, add ‘S’ to REF

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REF Description

4.0mm Locking Instruments

702742 Drill Ø3.1mm x 204mm

702772 Tap Ø4.0mm x 140mm

702747 Screwdriver T15, L200mm

702753 Solid Screwdriver T15, L115mm

702732 Screw Holding Sleeve

702702 K-Wire Sleeve

702707 Drill Sleeve

702884 Direct Depth Gauge for Locking Screws

702750 Torque Limiter T15/4.0mm

702762 Locking Insert Inserter 4.0mm

702427 T-Handle small, AO Fitting

38111090 K-Wire Ø2.0mm x 230mm

702767 Locking Insert Extractor

702778 Handle for Plate Insertion

702712 Drill/K-Wire Measure Gauge

702776 Temporary Plate Holder

702776-1 Spare Shaft for Temporary Plate Holder

702919 Soft Tissue Spreader

702961 Trocar (for Soft Tissue Spreader)

702782 Soft Tissue Elevator

702756 Bending Irons (x2)

Ordering Information - 4.0mm Instruments

Ordering Information - 4.0mm Instruments

REF Description

4.0mm Locking Instruments

702723 Aiming Block, Distal Anterolateral Tibia, Left

702722 Aiming Block, Distal Anterolateral Tibia, Right

702725 Aiming Block, Distal Medial Tibia, Left

702724 Aiming Block, Distal Medial Tibia, Right

702720-2 Spare Set Screw for Tibia Aiming Block

702797 Plate Trial/Shaft Hole Locator - Distal Anterolateral Tibia

702795 Plate Trial/Shaft Hole Locator - Distal Medial Tibia

SPS Standard Instruments700347 Drill Bit Ø2.5mm x 125mm, AO700355 Drill Bit Ø2.5mm x 230mm, AO700353 Drill Bit Ø3.5mm x 180mm, AO702804 Tap Ø3.5mm x 180mm, AO702805 Tap Ø4.0mm x 180mm, AO702418 Double Drill Guide Ø2.5/3.5mm702822 Drill Sleeve Handle702825 Drill Sleeve Ø2.5mm Neutral702829 Drill Sleeve Ø2.5mm Compression702831 Drill Sleeve Ø2.5mm Buttress702709 Percutaneous Drill Sleeve Ø2.5mm702957 Percutaneous Drill Sleeve Ø2.5mm Neutral702879 Depth Gauge 0-150mm for Screws Ø3.5/4.0, Titanium702841 Screwdriver Hex 2.5mm for Standard Screws L200mm702485 Solid Screwdriver Hex 2.5mm for Standard Screws L115mm702490 Screwdriver Holding Sleeve for Screws Ø3.5/4.0mm702428 Tear Drop Handle, small, AO Fitting900106 Screw Forceps390192 K-Wires 2.0mm x 150mm

Other Instruments

702968 Locking Insert Forceps

702671 Guide for Centering Pin

702673 Centering Pin

702675 Adapter for Centering Pin

702755 Torque Tester with Adapters

981093 X-Ray Template, Distal Anterolateral Tibia981092 X-Ray Template, Distal Medial Tibia

Cases and Trays902955 Metal Base - Instruments902929 Lid for Base - Instruments902930 Instrument Tray 1 (Top)902931 Instrument Tray 2 (Middle)902963 Instrument Tray 3 (Bottom) with space for Locking Insert Forceps Instrumentation902932 Screw Rack902949 Metal Base - Screw Rack902950 Metal Lid for Base - Screw Rack902947 Metal Base - Implants902935 Implant Tray - Distal Anterolateral Tibia902936 Implant Tray - Distal Medial Tibia902939 Lid for Base - Distal Lateral Tibia902940 Lid for Base - Distal Medial Tibia902958 Locking Insert Storage Box 4.0mm

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Additional Information

AdvantagesInjectable or Manual Implantation

HydroSet can be easily implanted viasimple injection or manual applicationtechniques for a variety of applications.

Fast Setting

HydroSet has been specificallydesigned to set quickly once implantedunder normal physiological conditions,potentially minimizing procedure time.

Isothermic

HydroSet does not release any heat as itsets, preventing potential thermalinjury.

Excellent Wet-FieldCharacteristics

HydroSet is chemically formulated toset in a wet field environmenteliminating the need to meticulouslydry the operative site prior toimplantation.2

Osteoconductive

The composition of hydroxyapititeclosely match that of bone mineralthus imparting osteoconductiveproperties.3

Augmentation of ProvisionalHardware during surgicalprocedure

HydroSet can be drilled and tapped toaccommodate the placement ofprovisional hardware.

Tibia Pilon Void Filling

Scanning Electron Microscope image of HydroSet materialcrystalline microstructure at 15000x magnification

HydroSet is an injectable, sculptableand fast-setting bone substitute.HydroSet is a calcium phosphatecement that converts to hydroxyapatite,the principle mineral component ofbone. The crystalline structure andporosity of HydroSet makes it aneffective osteoconductive andosteointegrative material, withexcellent biocompatibility andmechanical properties1. HydroSet wasspecifically formulated to set in a wetfield environment and exhibitsoutstanding wet-field characteristics.2

The chemical reaction that occurs asHydroSet hardens does not release heatthat could be potentially damaging tothe surrounding tissue. Once set,HydroSet can be drilled and tapped toaugment provisional hardwareplacement during the surgicalprocedure. After implantation, theHydroSet is remodeled over time at arate that is dependent on the size of thedefect and the average age and generalhealth of the patient.

Indications

HydroSet is a self-setting calciumphosphate cement indicated to fillbony voids or gaps of the skeletalsystem (i.e. extremities, craniofacial,spine, and pelvis). These defects maybe surgically created or osseous defectscreated from traumatic injury to thebone. HydroSet is indicated only forbony voids or gaps that are notintrinsic to the stability of the bonystructure.

HydroSet cured in situ provides anopen void/gap filler than can augment provisional hardware (e.g K-Wires,Plates, Screws) to help support bonefragments during the surgicalprocedure. The cured cement acts onlyas a temporary support media and isnot intended to provide structuralsupport during the healing process.

References1. Chow, L, Takagi, L. A Natural Bone Cement – A Laboratory Novelty Led to the Development ofRevolutionary New Biomaterials. J. Res. Natl. Stand.Technolo. 106, 1029-1033 (2001).

2. 1808.E703. Wet field set penetration (Data on file at Stryker)

3. Dickson, K.F., et al. The Use of BoneSourceHydroxyapatite Cement for Traumatic MetaphysealBone Void Filling. J Trauma 2002; 53:1103-1108.

HydroSetInjectable HA

Note:For more detailed informationrefer to Literature No. 90-079001275

Note:Screw fixation must be providedby bone

Ordering Information

Ref Description397003 3cc HydroSet397005 5cc HydroSet397010 10cc HydroSet397015 15cc HydroSet

23

Notes

Stryker Trauma AGBohnackerweg 1CH-2545 SelzachSwitzerland

www.osteosynthesis.stryker.com

This document is intended solely for the use of healthcare professionals. A surgeon must always rely on his or her ownprofessional clinical judgment when deciding whether to use a particular product when treating a particular patient.Stryker does not dispense medical advice and recommends that surgeons be trained in the use of and particular productbefore using it in surgery. The information presented in this brochure is intended to demonstrate a Stryker product.Always refer to the package insert, product label and/or user instructions including the instructions for Cleaning andSterilization (if applicable) before using any Stryker products. Products may not be available in all markets. Productavailability is subject to the regulatory or medical practices that govern individual markets. Please contact your Strykerrepresentative if you have questions about the availability of Stryker products in your area.

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the followingtrademarksor service marks: Stryker, AxSOS, HydroSet.

All other trademarks are trademarks of their respective owners or holders.The products listed above are CE marked.

Literature Number: 982279LOT E3309

US Patents pending

Copyright © 2009 Stryker