st360°® spinal fixation system surgical technique · rod clamp (large, small) 07.00447.001 &...
TRANSCRIPT
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
Additional Placement
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
Additional Placement
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
Additional Placement
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
Lock Nut Final Tightening
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
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 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
07.00319.012 4.5x30mm Polyaxial Screw 2
07.00319.013 4.5x35mm Polyaxial Screw 2
07.00319.014 4.5x40mm Polyaxial Screw 4
07.00319.015 4.5x45mm Polyaxial Screw 4
07.00319.021 5.5x25mm Polyaxial Screw 2
07.00319.022 5.5x30mm Polyaxial Screw 2
07.00319.023 5.5x35mm Polyaxial Screw 4
07.00319.024 5.5x40mm Polyaxial Screw 6
07.00319.025 5.5x45mm Polyaxial Screw 4
07.00319.026 5.5x50mm Polyaxial Screw 2
07.00319.027 5.5x55mm Polyaxial Screw 2
07.00319.032 6.5x30mm Polyaxial Screw 2
07.00319.033 6.5x35mm Polyaxial Screw 6
07.00319.034 6.5x40mm Polyaxial Screw 8
07.00319.035 6.5x45mm Polyaxial Screw 8
07.00319.036 6.5x50mm Polyaxial Screw 6
07.00319.037 6.5x55mm Polyaxial Screw 4
07.00319.038 6.5x60mm Polyaxial Screw 2
07.00319.039 6.5x65mm Polyaxial Screw 2
07.00319.042 7.5x30mm Polyaxial Screw 2
07.00319.043 7.5x35mm Polyaxial Screw 4
07.00319.044 7.5x40mm Polyaxial Screw 4
07.00319.045 7.5x45mm Polyaxial Screw 4
07.00319.046 7.5x50mm Polyaxial Screw 4
07.00319.053 8.5x35mm Polyaxial Screw 2
07.00319.054 8.5x40mm Polyaxial Screw 2
07.00319.055 8.5x45mm Polyaxial Screw 2
ST360° Screw Implant Kit
ST360° Kit ContentsKit Number 07.00512.002
46
Part Number Description Standard Kit Quantity
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
07.00401.002 5.5x13mm Fixed Transverse Connector 1
07.00401.003 5.5x15mm Fixed Transverse Connector 1
07.00401.004 5.5x17.5mm Fixed Transverse Connector 1
07.00401.005 5.5x20mm Fixed Transverse Connector 1
07.00401.006 5.5x22.5mm Fixed Transverse Connector 1
07.00401.007 5.5x25mm Fixed Transverse Connector 1
07.00401.008 5.5x27.5mm Fixed Transverse Connector 1
07.00401.009 5.5x30mm Fixed Transverse Connector 1
07.00401.010 5.5x32.5mm Fixed Transverse Connector 1
07.00401.011 5.5x35mm Fixed Transverse Connector 1
07.00401.012 5.5x37.5mm Fixed Transverse Connector 1
07.00401.013 5.5x40mm Fixed Transverse Connector 1
07.00401.014 5.5x42.5mm Fixed Transverse Connector 1
07.00401.015 5.5x45mm 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
07.00857.003 5.5mm Top-Loading Rod, 23–30mm, Offset 4
07.00857.004 5.5mm Top-Loading Rod, 23–30mm, Even 2
07.00857.006 5.5mm Top-Loading Rod, 30–37mm, Even 2
7055-0001-00 Set Screw 6
ST360° 5.5mm Rod Connector Implant Kit
Kit Number 07.00510.002
47
Part Number Description Standard Kit Quantity
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
Part Number Description Standard Kit Quantity
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
07.00405.001 6.35x11mm Fixed Transverse Connector 1
07.00405.002 6.35x13mm Fixed Transverse Connector 1
07.00405.003 6.35x15mm, Fixed Transverse Connector 1
07.00405.004 6.35x17.5mm Fixed Transverse Connector 1
07.00405.005 6.35x20mm Fixed Transverse Connector 1
07.00405.006 6.35x22.5mm Fixed Transverse Connector 1
07.00405.007 6.35x25mm Fixed Transverse Connector 1
07.00405.008 6.35x27.5mm Fixed Transverse Connector 1
07.00405.009 6.35x30mm Fixed Transverse Connector 1
07.00405.010 6.35x32.5mm Fixed Transverse Connector 1
07.00405.011 6.35x35mm Fixed Transverse Connector 1
07.00405.012 6.35x37.5mm Fixed Transverse Connector 1
07.00405.013 6.35x40mm 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
07.00858.001 6.35mm Top-Loading Rod, 20–25mm, Offset 2
07.00858.003 6.35mm Top-Loading Rod, 23–30mm, Offset 4
07.00858.004 6.35mm Top-Loading Rod, 23–30mm, Even 2
07.00858.006 6.35mm Top-Loading Rod, 30–37mm, Even 2
7055-0001-00 Set Screw 6
ST360° 6.35mm Rod Connector Implant Kit
Kit Number 07.00511.002
49
Part Number Description Standard Kit Quantity
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
07.00432.003 6.5mm Tap, Cannulated 1
07.00432.004 7.5mm Tap, Cannulated 1
07.00432.005 8.5mm 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
Part Number Description Standard Kit Quantity
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
Part Number Description Standard Kit Quantity
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
Part Number Description Standard Kit Quantity
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
Part Number Description Standard Kit Quantity
07.00319.034 6.5x40mm Polyaxial Screw 2
07.00319.035 6.5x45mm Polyaxial Screw 2
07.00319.036 6.5x50mm Polyaxial Screw 2
07.00319.044 7.5x40mm Polyaxial Screw 2
07.00319.045 7.5x45mm Polyaxial Screw 2
07.00319.046 7.5x50mm Polyaxial Screw 2
07.00319.055 8.5x45mm Polyaxial Screw 2
Part Number Description Standard Kit Quantity
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
Part Number Description
07.00408.004 5.5mm x 60–70mm
Part Number Description
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
Part Number Description
Part Number Description
Part Number Description
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
Part Number Description
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
Part Number Description
7500-5601-00 5.5mm x 10cm
Part Number Description
07.00320.004 5.5mm x 5cm
07.00320.005 5.5mm x 4cm
Part Number Description
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
Part Number Description
Part Number Description
Part Number Description
Part Number Description
54
Part Number Description
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.