ST360°® Spinal Fixation System Surgical Technique · Rod Clamp (Large, Small) 07.00447.001 & 07.00447.002 Alternative for secure rod placement. Set Screw Driver 07.00452.001 Assembles

Solutions by the people of Zimmer Spine.zimmerspine.com

ST360°®

Spinal Fixation System

Surgical Technique

An adaptable solution From the people of Zimmer Spine.

At Zimmer Spine we know that no two patients are alike. That’s why we provide a wide range of spinal solutions designed to preserve, protect and adapt to challenging patient anatomies. Solutions like the ST360° Spinal Fixation System that accommodate anatomical variations and decrease stress and loading intraoperatively. The ST360° Spinal Fixation System is a proven solution that’s backed by a long history of success, and it can only be found at Zimmer Spine.

Table of ContentsIntroduction 2

Indications/Contraindications 4

Implants 6

Instruments 8

Surgical Technique 16

Compression Technique 32

Distraction Technique 33

Reduction Technique 34

Revision Technique 44

Kit Contents 45

Warnings and Precautions 55

4

Indications

The ST360°® Spinal System is intended for posterior, noncervical pedicle and nonpedicle

fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of

discogenic origin with degeneration of the disc confirmed by history and radiographic studies);

spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures

(i.e., scoliosis, kyphosis, and/or lordosis), tumor; pseudoarthrosis, and failed previous fusion.

Pedicle screw fixation is limited to skeletally mature patients.

When used as a sacral screw system, the ST360° Spinal Fixation System is intended for use in the

treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with

degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis,

spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors,

spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal

fusion. When used for this indication, screws of the ST360° Spinal Fixation System are intended

for sacral iliac attachment only. Transverse connectors of the system are intended for posterior

thoracic and/or lumbar use only. As a whole, the levels of use for sacral screw fixation of this

system are T1 to the sacrum.

Indications/Contraindications

5

Contraindications

Contraindications of the ST360° Spinal Fixation System are similar to other commercially available

posterior spinal fixation systems of similar design and material. Contraindications include but are not

limited to the following:

• Use in the cervical spine

• Active systemic or local infection

• Obesity

• Pregnancy

• Mental illness

• Severe osteoporosis or osteopenia

• Metal sensitivity/allergies to the implant material

• Alcohol or drug abuse

• Patients are unwilling or unable to follow postoperative instructions

• Soft tissue deficit not allowing wound closure

• Any medical or physical condition that would preclude the potential benefit of spinal implant

surgery

• Congenital abnormalities, tumors or other conditions that would prevent secure component

fixation that has the potential to decrease the useful life of the device

• Any medical or mental condition which would exclude the patient or put the patient at high risk

from surgery of this severity

• For pedicle screw cases, inadequate pedicles of the thoracic, lumbar, and sacral vertebrae

6

ST360° Implants

Screw (4.5 – 8.5mm†) 07.00319.011 to 07.00319.058

5.5mm Rod, Curved (50 – 100mm†) 07.00320.001 to 07.00320.005

6.35mm Rod, Curved (50 – 100mm†) 07.00298.001 to 07.00298.005

5.5mm Rod, Hex End (100 – 470mm) 7500-5601-00 to 7500-5603

6.35mm Rod, Hex End (100 – 470mm) 07.00296.001 to 07.00296.003

5.5mm Rod, Straight (100 – 470mm†) 7500-5510-00 to 7500-5547-00

6.35mm Rod, Straight (100 – 470mm†) 07.00292.001 to 07.00292.003

Lateral Connector (Mini, S, M, L) 07.00295.001 to 07.00295.004

Left Offset Connector 007.00297.002

Right Offset Connector 07.00297.001

8mm Lock Nut 07.00326.001

Set Screw 7055-0001-00

† Additional sizes available by special order.

7

† Additional sizes available by special order.

5.5mm Top Loading Rod, Even† 07.00857.004, 07.00857.006

6.35mm Top Loading Rod, Even† 07.00858.004, 07.00858.006

5.5mm Top-Loading Rod, Offset† 07.00857.001, 07.00857.003

6.35mm Top-Loading Rod, Offset† 07.00858.001, 07.00858.005

5.5mm ATC Rod (Silver Insert)† 07.00408.001 to 07.00408.003

6.35mm ATC Rod (Gold Insert)† 07.00409.001 to 07.00409.003

5.5mm ATC Sleeve (Silver Insert) 07.00424.001

6.35mm ATC Sleeve (Gold Insert) 07.00425.001

5.5mm Fixed Transverse Connector (11 – 47.5mm, Silver Insert†) 07.00401.001 to 07.00401.015

6.35mm Fixed Transverse Connector (11 – 47.5mm, Gold Insert†) 07.00405.001 to 07.00405.015

8

ST360° Instruments

Bone Awl 07.00426.001

Perforates the bone for pedicle preparation in cases in which the Bone Awl represents the preferred method.

Bone Probe (Straight & Curved) 07.00427.001 & 7010-0063-01

Determines the depth of a prepared pedicle. Curved and Straight options available.

Note: Curved Bone Probes should not be utilized in conjunction with 4.5mm screws.

Pedicle Marker Inserter 07.00559.001

Guides either the Single- or Double-Banded Pedicle Marker into the pedicle canal.

Single-Banded Pedicle Marker 07.00560.001Double-Banded Pedicle Marker 07.00561.001

Placed in the pedicle canal to identify appropriate screw trajectory fluoroscopically. Single-band design indicates placement on the left pedicle; double-band design indicates placement on the right pedicle.

Straight Sound 7010-0007-01Curved Sound 7010-0008-01

Palpates the inner surface of the prepared pedicle to verify the pedicle wall’s integrity. Graduated to aid in the determination of hole depth.

Cannulated Tap (5.5 – 8.5mm) 07.00432.002 to 07.00432.005Non Cannulated Tap (4.5mm) 07.00431.001

Available as a cannulated instrument to facilitate pedicle preparation when tapping is the preferred method.

Note: All screws are self-tapping; the use of a tap is optional.

9

Ratchet Handle 07.00438.001

Attaches to Screw Driver for initial screw and Guide Pin placement. Also utilized for the removal or revision of system constructs.

Ratcheting T-Handle 07.00563.001

May be used in place of other ratcheting handles as dictated by surgeon preference.

T-Handle 07.00433.001

May be used in place of ratcheting handles as dictated by surgeon preference.

Screw Driver 07.00437.001

Assembles to Ratchet Handle for screw implantation.

Guide Pin 07.00434.001

Threads onto polyaxial screw and inserts into Screw Driver to direct implant into the prepared pedicle. Facilitates loading additional implants onto the placed screws, including lateral connectors and top-loading rods.

Guide Pin Guide 07.00435.001

Facilitates an alternative screw placement technique, interfacing with previously positioned screw heads as Guide Pins are passed down its shaft to thread onto the screws.

10

French Rod Bender 7010-0030-00

Contours rods as necessary to conform to the construct.

Tubular Rod Bender 7010-0034-01

Alternative instrument creates curvature in the rod prior to placement in the wound. Not compatible with 6.35mm diameter rods.

In Situ Rod Benders (5.5, 6.35mm) L: 07.00466.001, 07.00468.001 R: 07.00465.001 & 07.00467.001

Alternative instruments create curvature in the rod in situ.

Transverse Connector / Rod Holder 7010-0122-01

May be used to facilitate placement of either rods or transverse connectors in situ.

Hex Rod Wrench 7010-0134-00

May be used to rotate hex end rods in situ.

Rod Clamp (Large, Small) 07.00447.001 & 07.00447.002

Alternative for secure rod placement.

Set Screw Driver 07.00452.001

Assembles with Torque Limiting T-Handle for provisional tightening of lateral connectors’ set screws. This assembly may also be used to final tighten the set screws on an adjustable transverse connector.

3.5mm Hex Driver 07.00562.001

Provisionally tightens connector set screws and can be used to assist with removal of Guide Pins after Lock Nut is applied.

11

Torque-Limiting T-Handle 07.00446.001

In conjunction with Set Screw Driver, tightens lateral connectors’ set screws. May also be used in conjunction with Transverse Connector Nut Driver Shaft to install a transverse connector and tighten its lock nuts.

Lock Nut Starter 07.00439.001

Slides down Guide Pin to seat and provisionally tighten 8mm lock nuts onto lateral connectors and top-loading rods in situ.

Anti-Torque 07.00441.002

Provides anti-torque to aid final set screw tightening and final lock nut tightening.

Torque Wrench 07.00444.001

Works in conjunction with Anti-Torque to final tighten 8mm lock nuts.

Deflection Beam Torque Wrench 07.00443.001

Assembles to Lock Nut Driver/Socket and Nut Starter to final tighten 8mm lock nuts against the Anti-Torque Instrument.

Lock Nut Driver/Socket 07.00440.001

Assembles to Deflection Beam Torque Wrench to final tighten 8mm lock nuts against the Anti-Torque Instrument.

12

*Available by special order only.

Compressor 07.00448.001

Compresses construct against an adjacent fully tightened segment.

Under-Rod Compressor* 7010-0119-01

Alternative instrumentation to achieve compression.

Distractor 07.00449.001

Distracts construct against an adjacent fully tightened segment.

Under-Rod Distractor* 7010-0120-01

Alternative instrumentation to achieve distraction.

13

Right Angle Anti-Torque 07.00442.001

Provides anti-torque for final lock nut tightening of top-loading rods.

Top Loading Rod Instrumentation

14

Transverse Connector Instrumentation

Transverse Connector Gauge 07.00566.001

Determines appropriate length transverse connector for construct.

Transverse Connector Rod Bender 07.00469.001

Facilitates rod bending for fixed transverse connectors.

Transverse Connector Nut Driver 07.00450.001

Assembles with Torque-Limiting T-Handle to install a fixed transverse connector and final tighten its lock nuts.

15

Reduction Instrumentation

Reduction Guide Pin Guide 07.00653.001

Directs the placement of Reduction Guide Pins.

Proximal Threaded Reduction Guide Pin (Grade 2, 4) 07.00649.001 & 07.00649.002

Passes through the Reduction Guide Pin Guide and engages with toggle post to facilitate reduction.

Reduction Nut Starter 07.00650.001

Facilitates placement of lock nut in reduction constructs. Additionally, engages with Tri-Lobe Nut to facilitate anatomical reduction.

Tri-Lobe Nut 07.00651.001

Engages with Reduction Nut Starter and rotates to reduce anatomy and then advance the lock nut onto the construct.

16

Depth Determination

Insert the Straight Bone Probe into the

established entry site, gently pressing through

the pedicle canal to determine hole depth.

Note: Curved Bone Probes should not be used for 4.5mm screws.

Step 2

Surgical Technique

Pedicle Preparation

Determine the pedicle canal entry site. Prepare the pedicle canal using preferred instrumentation.

Pedicle Marker Placement

Pedicle Markers may be placed to identify

appropriate screw trajectory via lateral x-ray/

fluoroscopy view.

Note: Different notches on the pedicle markers are used to indicate left- or right-side placement.

Step 3

Patient Positioning

Patient Positioning

Place the patient on a radiolucent operating

table in the prone position. Drape the patient for

posterior spinal fusion.

Step 1

17

Pedicle Sound

Insert a Straight or Curved Sound to palpate

the hole’s inner surface to verify pedicle wall

integrity.

Step 4

Step 5 Option 1: Polyaxial Screw Insertion with Guide Pin

Screw/Guide Pin Assembly

Select the appropriate polyaxial screw length.

Screw the Guide Pin into the polyaxial screw head.

Step 5 Option 1b

Screw Driver Assembly

Assemble the Screw Driver Shaft and Ratchet Handle.

Note: All screws are self-tapping. The use of a Tap is optional.

Step 5 Option 1a

18

Guide Pin/Screw Driver Assembly

Insert the screw with Guide Pin into the Screw

Driver Shaft until the screw head is fully captured

within the Screw Driver.

Step 5 Option 1c

Additional Placement

Repeat the process until all Guide Pins and screws

are placed.

Step 5 Option 1e

Insertion

Insert the polyaxial screw into the desired pedicle

until the base of the screw head makes contact

with the bone.

Pull the Screw Driver Shaft from the Guide Pin and

screw.

Step 5 Option 1d

19

Screw/Screw Driver Assembly

Insert the screw head into the Screw Driver Shaft

until the screw head is recessed.

Step 5 Option 2b

Step 5 Option 2: Polyaxial Screw Insertion without Guide Pin

Screw Driver Assembly

Assemble the Screw Driver Shaft and

Ratcheting Handle.

Step 5 Option 2a

Insertion

Insert the polyaxial screw into the desired pedicle

until the base of the screw head makes contact

with the bone.

Pull the Screw Driver Shaft from the screw head.

Step 5 Option 2c

20


Repeat the process until all screws are placed.

Step 5 Option 2d

Guide Pin Guide Positioning

Position the Guide Pin Guide on the screw head

with the funnel side down.

Step 5 Option 2e

Guide Pin Placement

Drop the Guide Pin into the Guide Pin Guide.

Tighten the Guide Pin with three clockwise

revolutions of the Guide Pin shaft.

Remove the Guide Pin Guide.

Step 5 Option 2f

21

Step 6 Option 1: Lateral Connector Placement

The following illustrates the standard technique for placing lateral connectors. For instructions on the

placement of lateral connectors with anatomical reduction capabilities, see the “Reduction” section of

this document.

Rod Selection

Select the appropriate diameter and length rod. Cut

rod to a desired length.

Contour the rods as needed. Pre-lordosed rods

are also available.

Step 6 Option 1a


Repeat the process until all Guide Pins are placed.

Step 5 Option 2g

22

Lateral Connector Placement

Select the appropriate lateral connectors and

place them on the rods. Provisionally tighten

the set screws to the rods.

Step 6 Option 1b

Instrument Assembly

Assemble the Set Screw Driver Shaft and Torque-

Limiting T-Handle. If the Guide Pins are not

already in position, place them on the screw

toggles now.

Rod & Lateral Connector Placement

Hold the Guide Pins in a “stair step” formation.

Slide the connector/rod assembly over the Guide

Pins down to the screws.

Step 6 Option 1c

Step 6 Option 1d

23

Lock Nut Provisional Tightening

Provisionally tighten the nut with the Lock Nut

Starter.

Step 6 Option 1g

Lock Nut Seating

Lower the Lock Nut Starter onto a lock nut and

push to snap into place. Slide the Lock Nut Starter

over a Guide Pin and gently press down on the

lateral connector with the Lock Nut Starter to seat

the nut.

Implant Adjustment (if necessary)

If the nut does not seat, continue to place gentle

downward pressure on the Lock Nut Starter and

rotate the Guide Pin clockwise until the nut and

screw toggle engage.

Step 6 Option 1e

Step 6 Option 1f

24


Remove the Nut Starter and Guide Pin.

Repeat the process until all nuts are placed and

provisionally tightened.

Final Set Screw Tightening

Assemble the Torque-Limiting T-Handle and the

Set Screw Driver Shaft. Position the Anti-Torque

Instrument over a lateral connector at the set

screw location. Insert the Set Screw Driver through

the cannulated hole at the top of the Anti-Torque

Instrument and place it into the set screw.

Tighten the set screw until you hear an audible

click (50 in-lb). Repeat the process until the

remaining set screws are tightened.

Note: Ensure the Set Screw Driver Shaft is fully engaged in the head of the set screw.

Note: All set screws must be final tightened prior to final tightening of lock nuts.

Step 6 Option 1h

Step 6 Option 1i

25

Lock Nut Seating

Lower the Lock Nut Starter onto a lock nut and

push to snap into place.

Slide the Lock Nut Starter over a Guide Pin and

gently press down on the TLR with the Lock Nut

Starter to seat the nut. If the nut does not seat,

continue to place gentle downward pressure on

the Lock Nut Starter and rotate the Guide Pin

clockwise until the nut and screw toggle engage.

Provisionally tighten the nut with the Lock Nut

Starter.

Remove the Nut Starter and Guide Pin. Repeat

the process until both lock nuts are placed and

provisionally tightened.

Step 6 Option 2b

Step 6 Option 2: One-Level Top-Loading Rod

TLR Placement

Select the appropriate top-loading rod (TLR).

Hold the Guide Pins in a “stair step” formation

and slide the TLR over the Guide Pins down to

the screws.

Step 6 Option 2a

26

Torque-Wrench Positioning

Place the Torque Wrench over the lock nut to be

tightened.

Anti-Torque Positioning

Position the Anti-Torque Instrument over a lateral

connector at the set screw location.

Note: Where possible, the Anti-Torque Instrument should be placed on the same connector as the nut being tightened.

Step 7 Option 1b

Step 7 Option1a

Final Lock Nut Tightening

Step 7 Option 1: Standard Final Tightening, Lateral Connector Constructs

For this method, Guide Pins and Nut Starters must be removed from the construct.

27

Lock Nut Final Tightening

Tighten the nut until the two half circles on the

Torque Wrench Handle align and form a complete

circle (100 in-lb). Repeat the process until the

remaining lock nuts are tightened.

Step 7 Option1c

28


Placing one hand over the palm swivel and the

other onto the handle of the Deflection Beam

Torque Wrench, tighten the lock nut to 100 in-lb,

while your assistant maintains rotational stability

of the Anti-Torque Instrument.

Step 7 Option2b

Instrumentation Assembly

Assemble the Lock Nut Driver/Socket to the

Deflection Beam Torque Wrench.

Position the Lock Nut Starter on the nut to be

tightened, if not already in place. Slide the

Deflection Beam Torque Wrench with the Lock Nut

Driver/Socket over the hex of the Nut Starter.

Note: Where possible, the Anti-Torque Instrument should be placed on the same connector as the lock nut being tightened.

Step 7 Option 2a

Step 7 Option 2: Alternative Final Tightening, Lateral Connector Construct

This method may require an assistant for proper construct tightening. The Lock Nut Starters should be

on the lock nuts for this method. If the Guide Pins are still in place, they may remain, as they will not

interfere with nut tightening.

29

Instrument Placement

Position the Right-Angled Anti-Torque Instrument

over a TLR on the rod portion. Place the Torque

Wrench over the lock nut to be tightened.

Step 7 Option 3a

Step 7 Option 3: Final Tightening, Top-Loading Rod (TLR) Construct


Tighten the nut until the two half circles on the

Torque Wrench Handle align and form a complete

circle (100 in-lb). Repeat the process until the

remaining lock nuts are tightened.

Step 7 Option 3b

30

Implant Adjustment

Transverse connectors may be either fixed or

adjustable in length.

If using an adjustable transverse connector, it may

be necessary to loosen the adjustable transverse

connector set screw to allow free movement of the

connector rod in the sleeve.

Implant Selection

Transverse Connectors may be used to connect

rod segments.

Determine the appropriate Transverse Connector

length, using the Transverse Connector Gauge.

Step 8

Step 9

Transverse Connector Option (if necessary)

31

Option 2: Adjustable Transverse Connector Placement

Using the Transverse Connector Nut Driver, snap

the connector over one rod and then over the

other. Tighten the nuts until you hear an audible

click from the Torque-Limiting T-Handle (50 in-lb).

Use the Torque-Limiting T-Handle/Set Screw

Driver Assembly to tighten the set screw until you

hear an audible click (50 in-lb).

Option 1: Fixed Transverse Connector Placement

Using the Transverse Connector Nut Driver, snap

the connector over one rod and then over the

other. Tighten the nuts until you hear an audible

click from the Torque-Limiting T-Handle (50 in-lb).

Step 10 Option 2

Step 10 Option1

Instrument Assembly

Assemble the Torque-Limiting T-Handle and the

Transverse Connector Nut Driver Shaft.

Step 10

32

If compression is necessary, perform these steps prior to final tightening the construct.

Provisionally tighten the set screw on one side of the segment being translated, while leaving the set

screw on the contralateral side loose.

Note: If compression against an adjacent segment is not desirable, attach a Rod Clamp to the rod to provide a stable structure against which to compress.

Compression Option

Option 1: Compression for Lateral Connector Construct

Perform compression against the provisionally

tightened assembly.

After achieving the desired amount of correction,

perform final tightening of the set screws.

Option 1

Option 2: Compression for Top-Loading Rod Constructs

Fully tighten the lock nut on one side of the TLR

being translated, while leaving the lock nut on the

opposite end loose.

Perform compression against the fully tightened

end. After achieving the desired amount of

correction, perform final tightening of the

adjacent lock nut.

Option 2

Compression Technique

33

If distraction is necessary, perform these steps prior to final tightening the construct.

Provisionally tighten the set screw on one side of the segment being translated, while leaving the set

screw on the contralateral side loose.

Note: If distraction against an adjacent segment is not desirable, attach a Rod Clamp to the rod to provide a stable structure against which to distract.

Distraction Option

Option 1: Distraction for Lateral Connector Construct

Perform distraction against the provisionally

tightened assembly.

After achieving the desired amount of correction,

perform final tightening of the set screws.

Option 2: Distraction for Top-Loading Rod Construct

Fully tighten the lock nut on one side of the TLR

being translated, while leaving the lock nut on the

opposite end loose .

Perform distraction against the fully tightened

end. After achieving the desired amount of

correction, perform final tightening of the

adjacent lock nut.

Option 1

Option 2

Distraction Technique

34

Reduction Technique

Reductions can be performed utilizing the system’s lateral connectors or top-loading rod.

For either technique, start the procedure by inserting polyaxial screws as described earlier in the

"Surgical Technique" section of this manual.

Reduction Option

Standard Guide Pin Placement

Place Standard Guide Pins at L4 and S1 if they

were not placed during screw insertion.

Reduction Guide Pin Guide Placement

Place Reduction Guide Pins at L5 with the

Reduction Guide Pin Guide. Place the Reduction

Guide Pin Guide over the toggle of the L5 screw.

Option 1: Reduction Option for Lateral Connector Constructs

Option 1 Step 1

Option 1 Step 2

35

Lateral Connector Placement

Select the appropriate lateral connectors and

place them on the rods. Provisionally tighten the

set screws to the rods.

Slide the connector/rod assembly over the Guide

Pins down to the screws.

Tighten the set screws and lock nuts at S1 to full

torque.

Reduction Guide Pin Placement

Pass the Reduction Guide Pin through the

Reduction Guide Pin Guide and engage it with

the toggle in a clockwise motion. Ensure that the

Reduction Guide Pin is fully engaged with the

toggle post by tightening with the 3.5mm Hex

Driver. This will enable the lock nut to transition

from the guide pin to the toggle post.

Note: Full engagement of Guide Pin to toggle post must be accomplished via use of the Reduction Guide Pin Guide.

Rod Selection

Select the appropriate diameter and length rod.

Cut rod to a desired length.

Contour the rods as needed. Pre-lordosed rods

are also available.

Option 1 Step 3

Option 1 Step 4

Option 1 Step 5

36

Tightening

Provisionally tighten the lock nuts at L4 to maintain

active motion of the polyaxial feature. To allow axial

translation of the connector during reduction, do not

tighten the set screws at L4 at this point.

Determine the desired cephalad/caudal and

dorsal/ventral angle of the L5 connector. Lock

down the set screw on L5 to full torque using the

Set Screw Driver, Anti-Torque and 50in-lb Torque-

Limiting Wrench (blue handle).

Note: Optional removal of the L4 Guide Pin and Nut Starter can occur at this point if desired.

Reduction Nut Starter

Slide the Reduction Nut Starter with the lock nut

over the Reduction Guide Pin until the lock nut

encounters the lateral connector.

Option 1 Step 6

Option 1 Step 7

Tri-Lobe Nut Loading

Load the Tri-Lobe Nut onto the Reduction Guide

Pin.

Flats within the Tri-Lobe Nut align to flats on the

Reduction Guide Pin. Rotate the paddle handle

of the Tri-Lobe Nut clockwise until it is parallel

with the rod. Handle must be rotated clockwise to

ensure the Reduction Guide Pin remains engaged

in toggle.

Option 1 Step 8

37

L5 Segment Reduction

Bilaterally advance the Tri-Lobe Nut to reduce the

L5 segment.

Note: The paddle of the Tri-Lobe Nut must remain in line (parallel) with the rod to ensure alignment of the toggle post and allow the toggle post to pass through the lateral connector. The paddle handle should only be rotated clockwise to realign the paddle handle with the rods.

Tri-Lobe Nut Adjustment

Advance the Tri-Lobe Nut by turning the Tri-Lobe

Thumb Tabs clockwise to the point of contact with

the Reduction Nut Starter.

Option 1 Step 9

Option 1 Step 10

38

Visual Confirmation

The Reduction Nut Starter has two wide bands

wrapping around the instrument. Three windows

passing through the instrument interrupt these

two bands. The Reduction Guide Pin has a single

band on it.

Continue advancing the Tri-Lobe Nut until

the single band on the Reduction Guide Pin

is aligned to the inferior (lower) band on

the Reduction Nut Starter. (The Tri-Lobe Nut

will become difficult to advance, and further

advancement of the Tri-Lobe Nut will start to bind

the lock nut with the toggle). At this point, rotate

the Reduction Nut Starter clockwise to advance

the lock nut onto the screw toggle.

Complete advancement of the lock nut can be

verified visually when the line on the Guide Pin lines

up with the superior (upper) line on the Nut Starter.

Instrumentation Removal

After the lock nuts have been fully advanced,

remove the Reduction Nut Starter, Tri-Lobe

Nut and Reduction Guide Pin. Loosen the

Tri-Lobe Nut on one screw by rotating the nut

counterclockwise, and then lifting it off of the

Reduction Guide Pin. Slide the 3.5mm Hex

Driver over the Reduction Guide Pin and rotate

counterclockwise to disengage. Remove the

Reduction Guide Pin and Reduction Nut Starter.

To remove instruments from the contra-lateral screw,

hold the Reduction Nut Starter stationary while turning

the paddle of the Tri-Lobe Nut counterclockwise three

revolutions. Lift off of the implant.

Follow standard technique for final set screw and

lock nut tightening at L4 and L5.

Option 1 Step 11

Option 1 Step 12

39

Option 2: Reduction Technique for Top-Loading Rod (TLR) Constructs

Standard Guide Pin Placement

Place Standard Guide Pins in the S1 screws. They

may be attached to the screw prior to or after

screw insertion.

Reduction Guide Pin Guide Placement

Use the Reduction Guide Pin Guide to place

Reduction Guide Pins at L5 after screw insertion.

Place the Reduction Guide Pin Guide over the

toggle of the L5 screw. Orient the Guide Pin Guide

with the flats on the polyaxial screw toggle post

so that the Guide Pin Guide is fully seated.

Reduction Guide Pin Placement

Pass the Reduction Guide Pin through the

Reduction Guide Pin Guide and engage it with

the toggle in a clockwise motion. Ensure that the

Reduction Guide Pin is fully engaged with the

toggle post by tightening with the 3.5mm Hex

Driver. This will enable the lock nut to transition

from the Guide Pin to the toggle post.

Note: Full engagement of Guide Pin to toggle post must be accomplished via use of the Reduction Guide Pin.

Option 2 Step 1

Option 2 Step 2

Option 2 Step 3

40

Top-Loading Rod (TLR) Placement

Slide the TLR over the Guide Pins.

Apply the lock nuts on S1 and tighten

to full torque as described in the standard

surgical technique. The angle of the TLR,

when tightened on the S1 screw, should

correspond to the amount of reduction

required.

Reduction Nut Starter

Slide the Reduction Nut Starter with lock nut

over the Reduction Guide Pin until the lock nut

encounters the TLR.

Tri-Lobe Nut Placement

Load the Tri-Lobe Nut onto the Reduction Guide

Pin.

Flats within the Tri-Lobe Nut align to the flats

on the Reduction Guide pin. Rotate the paddle

handle of the Tri-Lobe Nut clockwise until it is

perpendicular to the TLR. The handle must be

rotated clockwise to ensure the Proximal Guide

Pin remains engaged in toggle.

Option 2 Step 4

Option 2 Step 5

Option 2 Step 6

41

Advancing the Tri-Lobe Nut

Advance the Tri-Lobe Nut by turning the Tri-Lobe

Thumb Tabs clockwise to the point of contact with

the Reduction Nut Starter.

L5 Segment Reduction

Bilaterally advance the lock nuts to reduce the L5

segment.

Note: The paddle of the Tri-Lobe Nut must remain perpendicular with the TLR to ensure alignment of the toggle post and allow the toggle post to pass through the slot on the TLR. The paddle handle should only be rotated clockwise to realign the paddle handle with the rod.

Visual Confirmation

The Reduction Nut Starter has two wide bands

wrapping around the instrument. Three windows

passing through the instrument interrupt these two

bands. The Reduction Guide Pin has a single

band on it.

Continue advancing the Tri-Lobe Nut until the

single band on the Reduction Guide Pin is aligned

to the inferior (lower) band on the Reduction Nut

Starter. (The Tri-Lobe Nut will become difficult to

advance and further advancement of the Tri-Lobe

Nut will start to bind the lock nut with the toggle.)

Option 2 Step 7

Option 2 Step 8

Option 2 Step 9

42

Toggle Post Engagement

At this point, rotate the Reduction Nut Starter

clockwise to advance the lock nut onto the screw

toggle while keeping the paddle of the Tri-Lobe

Nut perpendicular to the TLR.

Visual Confirmation

Complete advancement of the lock nut can be

verified visually when the line on the Guide Pin

lines up with the superior (upper) line on the

Reduction Nut Starter.

Instrumentation Removal

After the lock nuts have been fully advanced,

remove the Reduction Nut Starter, Tri-Lobe

Nut and Reduction Guide Pin. Loosen the

Tri-Lobe Nut on the first screw by rotating

the nut counterclockwise, and lift it off of the

Reduction Guide Pin. Slide the 3.5mm Hex

Driver over the Reduction Guide Pin and rotate

it counterclockwise to disengage. Remove the

Reduction Guide Pin and Reduction Nut Starter.

Option 2 Step 11

Option 2 Step 12

Option 2 Step 10

43

Instrumentation Removal – Contra-lateral Screw

To remove the instruments from the contra-lateral

screw, hold the Reduction Nut Starter stationary

while turning the paddle of the Tri-Lobe Nut

counterclockwise three revolutions and remove

the instruments from the implant.

Follow standard technique for final set screw and

lock nut tightening at L4 and L5.

Option 2 Step 13

44

It may be necessary to use general surgical instruments to remove the implant.

Hardware Removal / Revision Option

Option 1: Lateral Connector Construct Removal (if necessary)

Option 2: Top-Loading Rod Construct Removal (if necessary)

Option1a: Lock Nut Removal

Position the Anti-Torque Instrument over the set screw on the lateral connector attached to the ST360° screw

that is being removed. Place the Torque Wrench over the lock nut on the same screw. Rotate the Torque Wrench

counterclockwise until the lock nut is loose, and then completely remove the lock nut from the toggle post of the

screw. Repeat this procedure for all lock nuts on the construct. The rod and lateral connectors can now be lifted off

of the ST360° screws as a unit.

Option1b: Pedicle Screw Removal

Assemble the Ratchet Handle and the Screw Driver Shaft. Slide the Screw Driver over the head of the screw to

be removed. Turn the Ratchet Handle counterclockwise until the ST360° screw is removed. Repeat for all of the

ST360° pedicle screws.

Carefully examine the operative site to ensure that all hardware has been removed.

Option 2a: Lock Nut Removal

Position the Right-Angled Anti-Torque Instrument on the rod portion of the TLR and the Axial Torque Wrench

over the lock nut to be removed. Turn the Torque Wrench counterclockwise until the lock nut is loose, and then

completely remove the lock nut from the toggle post of the screw. Repeat this procedure for all lock nuts on the

construct. The TLR can now be lifted off of the ST360° screw.

Option 2b: Pedicle Screw Removal

Assemble the Ratchet Handle and the Screw Driver Shaft. Slide the Screw Driver over the head of the screw to

be removed. Turn the Ratchet Handle counterclockwise until the ST360° screw is removed. Repeat for all of the

ST360° pedicle screws.

Carefully examine the operative site to ensure that all hardware has been removed.

Revision Technique

45

Part Number Description Standard Kit Quantity

07.00319.011 4.5x25mm Polyaxial Screw 2




























ST360° Screw Implant Kit

ST360° Kit ContentsKit Number 07.00512.002

46


07.00295.001 10–15mm Straight Connector, Small (Blue) 10

07.00295.002 12–18mm Straight Connector, Medium (Magenta) 6

07.00295.003 16–20mm Straight Connector, Large (Green) 2

07.00295.004 10–12mm Straight Connector, Mini (Light Blue) 4

07.00297.001 Offset Connector, Right (Gold) 2

07.00297.002 Offset Connector, Left (Silver) 2

07.00320.001 5.5mm x 10cm Rod, Curved 4

07.00320.002 5.5mm x 8cm Rod, Curved 2

07.00320.003 5.5mm x 6cm Rod, Curved 2

07.00326.001 8mm Lock Nut 30

07.00401.001 5.5x11mm Fixed Transverse Connector 1



07.00401.004 5.5x17.5mm Fixed Transverse Connector 1












07.00408.001 5.5mm ATC Rod, 30–40mm (Blue/Silver) 2

07.00408.002 5.5mm ATC Rod, 40–50mm (Magenta/Silver) 1

07.00408.003 5.5mm ATC Rod, 50–60mm (Green/Silver) 1

07.00424.001 5.5mm ATC Sleeve (Silver Insert) 4

07.00857.001 5.5mm Top-Loading Rod, 20–25mm, Offset 2


07.00857.004 5.5mm Top-Loading Rod, 23–30mm, Even 2


7055-0001-00 Set Screw 6

ST360° 5.5mm Rod Connector Implant Kit

Kit Number 07.00510.002

47


7500-5510-00 5.5mm x 10cm Rod, Standard 2

7500-5520-00 5.5mm x 20cm Rod, Standard 2

7500-5602-00 5.5mm x 20cm Rod, Hex End 2

7500-5603-00 5.5mm x 47cm Rod, Hex End 3

Kit Number 07.00510.002

48


07.00292.001 6.35mm x 10cm Rod, Standard 2

07.00292.002 6.35mm x 20cm Rod, Standard 2

07.00295.001 10–15mm Straight Connector, Small (Blue) 10

07.00295.002 12–18mm Straight Connector, Medium (Magenta) 6

07.00295.003 16–20mm Straight Connector, Large (Green) 2

07.00295.004 10–12mm Straight Connector, Mini (Light Blue) 4

07.00296.002 6.35mm x 20cm Rod, Hex End 2

07.00296.003 6.35mm x 47cm Rod, Hex End 3

07.00297.001 Offset Connector, Right (Gold) 2

07.00297.002 Offset Connector, Left (Silver) 2

07.00298.001 6.35mm x 10cm Rod, Curved 4

07.00298.002 6.35mm x 8cm Rod, Curved 2

07.00298.003 6.35mm x 6cm Rod, Curved 2

07.00326.001 8mm Lock Nut 30



07.00405.003 6.35x15mm, Fixed Transverse Connector 1











07.00409.001 6.35mm ATC Rod, 30–40mm (Blue/Gold) 2

07.00409.002 6.35mm ATC Rod, 40–50mm (Magenta/Gold) 1

07.00409.003 6.35mm ATC Rod, 50–60mm (Green/Gold) 1

07.00425.001 6.35mm ATC Sleeve (Gold Insert) 4





7055-0001-00 Set Screw 6

ST360° 6.35mm Rod Connector Implant Kit

Kit Number 07.00511.002

49


07.00426.001 Bone Awl 1

07.00427.001 Bone Probe, Straight 1

07.00431.001 4.5mm Tap, Non-Cannulated 1

07.00432.002 5.5mm Tap, Cannulated 1




07.00433.001 T-Handle 1

07.00434.001 Guide Pin 12

07.00435.001 Guide Pin Guide 1

07.00437.001 Screw Driver 2

07.00438.001 Ratchet Handle 2

07.00439.001 Lock Nut Starter 6

07.00441.002 Anti-Torque 1

07.00444.001 Torque Wrench 1

07.00450.001 Transverse Connector Nut Driver 1

07.00452.001 Set Screw Driver 2

07.00559.001 Pedicle Marker Inserter 1

07.00560.001 Single-Banded Pedicle Marker 3

07.00561.001 Double-Banded Pedicle Marker 3

07.00562.001 3.5mm Hex Driver 1

07.00563.001 Ratcheting T-Handle 1

7010-0007-01 Sound, Straight 1

7010-0008-01 Sound, Curved 1

7010-0063-01 Bone Probe, Curved 1

7010-0122-01 Transverse Connector/Rod Holder 1


07.00446.001 Torque-Limiting T-Handle

ST360° Instrument Set – Core

Additional Required Instrumentation

Kit Number 07.00494.002

The Torque-Limiting T-Handle is not part of any ST360° instrument set and must be ordered separately.

50


07.00440.001 Lock Nut Driver/Socket 1

07.00442.001 Right-Angle Anti-Torque 1

07.00443.001 Deflection Beam Torque Wrench 1

07.00447.002 Rod Clamp, Small 1

07.00448.001 Compressor 1

07.00449.001 Distractor 1

07.00465.001 5.5mm In-Situ Rod Bender, Right Curved 1

07.00466.001 5.5mm In-Situ Rod Bender, Left Curved 1

07.00467.001 6.35mm In-Situ Rod Bender, Right Curved 1

07.00468.001 6.35mm In-Situ Rod Bender, Left Curved 1

07.00469.001 Transverse Connector Rod Bender 2

07.00566.001 Transverse Connector Gauge 1

7010-0030-00 French Rod Bender 1

7010-0034-01 Tubular Rod Bender 1

7010-0134-00 Hex Rod Wrench 1


07.00649.001 Proximal Threaded Reduction Guide Pin, Grade 2 2

07.00649.002 Proximal Threaded Reduction Guide Pin, Grade 4 2

07.00650.001 Reduction Nut Starter 2

07.00651.001 Tri-Lobe Nut 2

07.00653.001 Reduction Guide Pin Guide 1

ST360° Instrument Set – Auxiliary

ST360° Spondy Reduction Instrument Set

Kit Number 07.00495.002

Kit Number 07.00687.002

51










07.00429.001 Single-Banded Pedicle Marker, Long 3

07.00430.001 Double-Banded Pedicle Marker, Long 3

ST360° Spondy Reduction Implant Set

ST360° Long Pedicle Marker Kit

Kit Number 07.00687.001

Kit Number 07.00564.001

52

Part Number Description

07.00401.016 5.5mm x 47.5mm

07.00401.017 5.5mm x 50mm

07.00401.018 5.5mm x 52.5mm

07.00401.019 5.5mm x 55mm

07.00401.020 5.5mm x 57.5mm

07.00401.021 5.5mm x 60mm

07.00401.022 5.5mm x 62.5mm

07.00401.023 5.5mm x 65mm


07.00408.004 5.5mm x 60–70mm


07.00857.002 5.5mm x 20–25mm Even

07.00857.005 5.5mm x 30–37mm Offset

Fixed Transverse Connectors

Adjustable Transverse Connector Rods

Top-Loading Rods

07.00405.016 6.35mm x 47.5mm

07.00405.017 6.35mm x 50mm

07.00405.018 6.35mm x 52.5mm

07.00405.019 6.35mm x 55mm

07.00405.020 6.35mm x 57.5mm

07.00405.021 6.35mm x 60mm

07.00405.022 6.35mm x 62.5mm

07.00405.023 6.35mm x 65mm

07.00409.004 6.35mm x 60–70mm

07.00858.002 6.35mm x 20–25mm Even

07.00858.005 6.35mm x 30–37mm Offset




The implants listed in this section are not included in any of the ST360° implant kits. They may be ordered

individually by part number.

ST360° Special-Order Implants

53


07.00319.016 4.5mm x 50mm

07.00319.047 7.5mm x 55mm

07.00319.048 7.5mm x 60mm

07.00319.056 8.5mm x 50mm

07.00319.057 8.5mm x 55mm

07.00319.058 8.5mm x 60mm

07.00319.063 9.5mm x 35mm


7500-5601-00 5.5mm x 10cm


07.00320.004 5.5mm x 5cm

07.00320.005 5.5mm x 4cm


7500-5547-00 5.5mm x 47cm

Polyaxial Screws

Rods, Hex End

Rods, Curved

Rods, Standard

07.00319.064 9.5mm x 40mm

07.00319.065 9.5mm x 45mm

07.00319.066 9.5mm x 50mm

07.00319.067 9.5mm x 55mm

07.00319.068 9.5mm x 60mm

07.00319.069 9.5mm x 65mm

07.00296.001 6.35mm x 10cm

07.00298.004 6.35mm x 5cm

07.00298.005 6.35mm x 4cm

07.00292.003 6.35mm x 47cm





54


07.00447.001 Rod Clamp, Large

7010-0119-01 Under-Rod Compressor

7010-0120-01 Under-Rod Distractor

The instruments listed in this section are not included in any of the ST360° instrument sets and are not necessary

in order to complete the procedure. They may be ordered separately to suit surgeon preference.

ST360° Optional Instruments

55

Warnings

The safety and effectiveness of pedicle screw spinal systems have been established only for

spinal conditions with significant mechanical instability or deformity requiring fusion with

instrumentation. These conditions are significant mechanical instability or deformity of the

thoracic, lumbar, and sacral spine secondary due to degenerative disc disease (DDD) (defined as

back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic

studies), spondylolisthesis; trauma (i.e., fracture or dislocation), spinal stenosis, deformities or

curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous

fusion. Pedicle screw fixation is limited to skeletally mature patients. The safety and effectiveness

of these devices for any other conditions are unknown.

Potential risks identified with the use of this system that may require additional surgery include

device component fracture, loss of fixation, non-union, fracture of the vertebrae, neurologic injury,

and vascular or visceral injury. The ST360° Top Loading Rods are intended for single-level use only.

Precautions

The implantation of pedicle screw spinal systems should be performed only by experienced spinal

surgeons with specific training in the use of this pedicle screw spinal system because this is a

technically demanding procedure presenting a risk of serious injury to the patient. This system

should only be used with instrumentation specifically designed for this system.

The ST360° Spinal Fixation System can only be used in conjunction with the components from

the Silhouette Spinal System®. Components of competitive spinal fixation systems should not be

used with components of the ST360° Spinal Fixation System due to the potential for accelerating

the corrosion process by the mixing of dissimilar materials. No component of the ST360° Spinal

Fixation System should be reused after being removed from the body. An implant should never be

resterilized after contact with body tissue or body fluids.

All implants and some instruments are intended for single use only; refer to the product label to

determine if the instrument is intended for single use only. Single use devices should not be re-

used. Possible risks associated with re-use of single use devices include:

• Mechanical malfunction

• Transmission of infectious agents

The ST360° Spinal Fixation System is intended to be used with bone graft which is required to

provide additional spinal support. Use of this product without bone graft or in cases that develop

into a non-union will eventually be unsuccessful. A successful result is not always achieved in

every surgical case. Posterior spinal fixation systems cannot withstand body loads without the

support of bone. In the event that bone is not provided to facilitate fusion, bending, loosening,

disassembling, and/or breakage of the implants will eventually occur.

The patients should be made aware that a successful result, as defined by reduced pain,

increased function, and the establishment of solid fusion, is not always achieved in every surgical

Warnings and Precautions

56

case. Proper patient selection will greatly affect the results. Patients who smoke have shown to

have an increased incidence of non-union. These patients should be informed of this increased

risk and counseled to discontinue tobacco use prior to and immediately after surgery. Obese,

malnourished, and/or alcohol abuse patients are also poor candidates for spinal fusion. Patients

with poor muscle tone and bone quality and/or nerve paralysis are also poor candidates for spinal

fusion. The use of autogenous bone graft has been shown to provide superior results compared to

the use of allograft bone graft material.

In addition to the above specified warnings and precautions, general surgical risks should be

explained to the patient prior to surgery.

Torque limiting instrument adjustment screws or caps with set screws should not be manipulated

during the cleaning process. Manipulation or disassembly of the instrument will affect the

calibration of the instrument and it will require re-calibration prior to use.

57

Notes

58

Notes

59

Notes

Silhouette Spinal System® Fixation is a trademark of Spinal Innovations, LLC.

Disclaimer:

This documentation is intended exclusively for physicians and is not intended for laypersons. Information on the products and procedures contained in this document is of a general nature and does not represent and does not constitute medical advice or recommendations. Because this information does not purport to constitute any diagnostic or therapeutic statement with regard to any individual medical case, each patient must be examined and advised individually, and this document does not replace the need for such examination and/or advice in whole or in part. Please refer to the package inserts for important product information, including, but not limited to, indications, contraindications, warnings, precautions, and adverse effects.

Contact your Zimmer Spine representative or visit us at www.zimmerspine.com

Manufactured by:

Zimmer Spine7375 Bush Lake RoadMinneapolis, MN 55439800.655.2614

zimmerspine.com

L1243 Rev. I (2016-04)(851S-1001-00)© 2016 Zimmer Spine, Inc.

Zimmer LimitedSN3 4FP, U.K.+44.1793.58.4500

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Please see the product Instructions for Use for a complete listing of the indications, contraindications, warnings, precautions and adverse effects.

Printed in U.S.A. Subject to change without notice.

Documents

ST360°® Spinal Fixation System Surgical Technique · Rod Clamp (Large, Small) 07.00447.001 & 07.00447.002 Alternative for secure rod placement. Set Screw Driver 07.00452.001 Assembles