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PangeaSystem. For deformity correction.synthes.vo.llnwd.net/o16/Mobile/Synthes North America/Product...

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Instruments and implants approved by the AO Foundation Pangea System. For deformity correction. Technique Guide
Transcript
Page 1: PangeaSystem. For deformity correction.synthes.vo.llnwd.net/o16/Mobile/Synthes North America/Product Sup… · Low Profile. Indications The Pangea Deformity Correction System consists

Instruments and implants approved by the AO Foundation

Pangea System. For deformitycorrection.

Technique Guide

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Introduction

Surgical Technique

Product Information

Table of Contents

Pangea System 2

Indications 4

Screw Insertion 5

Hook Placement 11

Rod Contouring 13

Rod Reduction and Construct Assembly 14

Deformity Correction 22

Distraction and Compression 24

Final Tightening 26

Transconnector Attachment 27

Transverse Bar Attachment 28

Implants 29

Instruments 33

Set Lists 42

Sterilization Parameters 42

Image intensifier control

Synthes Spine

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Pangea System

Simple

Locking cap eliminates cross-threadingand ensures construct rigidity.

Instruments optimize correction ofcomplex deformities.

2 Synthes Spine Pangea System

Versatile

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Strong

6.0 mm rods provide long-term stability and maintain deformity correction.

Synthes Spine 3

Screws and hooks minimize anatomicalinterference.

Low Profile

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Indications

The Pangea Deformity Correction System consists of non-cervical spinal fixation devices intended for use as a posteriorpedicle screw fixation system (T1–S2), a posterior hook fixationsystem (T1–L5), or as an anterolateral fixation system (T8–L5).Pedicle screw fixation is limited to skeletally mature patients.

Indications– Degenerative disc disease

– Spondylolisthesis

– Fracture

– Dislocation

– Deformities or curvatures (i.e., scoliosis, kyphosis, and/orlordosis, Scheuermann’s Disease)

– Tumor

– Stenosis

– Pseudoarthrosis

– Failed previous fusion

When treating patients with degenerative disc disease (DDD), transverse bars are not cleared for use as part of theposterior pedicle screw construct.

When used with 3.5 mm/6.0 mm parallel connectors, thePangea Deformity Correction System can be linked to theSynthes CerviFix System. In addition, when used with5.0 mm/6.0 mm parallel connectors, the Pangea DeformityCorrection System can be linked to the Synthes Small StatureUSS System. In addition, the Pangea Deformity CorrectionSystem can be interchanged with all USS 6.0 mm rods andtransconnectors.

Please refer to product insert (GP0001) for complete systemdescription, warnings and precautions.

4 Synthes Spine Pangea System

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Screw Insertion

Synthes Spine 5

1 Prepare pedicles and determine screw lengths

Instruments

03.622.005 Thoracic Pedicle Probe

388.536 Pedicle Probe with Palm Handle, for 4.0 mm/4.2 mm screws

388.655 Probe with Palm Handle

388.656 Awl with Palm Handle

388.657 Curved Probe with Palm Handle

Locate pedicles and use the awl to perforate the cortex. Usethe appropriate probe to open the pedicle canal. For selectingthe appropriate length screw, the markings on the probe indicate the pedicle depth.

All Pangea screws are self-tapping; however, if tapping ispreferred, use the appropriate tap and tap handle.

2a Insert Pangea monoaxial screw

Instrument

03.622.004 Pangea Footed Screwdriver with StraightHandle

Insert the self-retaining Pangea Footed Screwdriver into thehead of the appropriate monoaxial screw.

Insert the monoaxial screw into the prepared pedicle.Repeat for each screw.

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Figure 1 Figure 2

Figure 3 Figure 4

Screw Insertion continued

6 Synthes Spine Pangea System

2a Insert Pangea monoaxial screw continued

Option: Pangea Footed Screwdriver and Holding Sleeve

Instruments

03.622.003 Pangea Holding Sleeve

03.622.004 Pangea Footed Screwdriver with StraightHandle

Assemble Holding SleevePlace the Pangea Footed Screwdriver through the outersleeve and pull sleeve back until it contacts the screwdriverhandle (Figure 1).

Place the inner sleeve over the screwdriver and under theouter sleeve (Figure 2). Use the window on the outer sleeveto visualize the keyway that will secure the inner sleeve tothe screwdriver. The inner sleeve’s keyway should be insertedinto the protruding pin on the screwdriver shaft. Turn the inner sleeve into the slot to secure (Figure 3).

Insert screw into screwdriverAfter ensuring that the outer sleeve is fully retracted, insertthe screwdriver tip into the head of the appropriate monoax-ial screw. Push the outer sleeve down until it stops (Figure 4).Insert the monoaxial screw into the prepared pedicle.

Remove screwdriver from implantAfter the screw is inserted, pull the outer sleeve back to disengage the screwdriver from the screw.

Inner sleeve Outer sleeve

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Synthes Spine 7

Alternative screwdrivers for monoaxial screw insertionwith Pangea Holding Sleeve

03.620.005 Ratchet T-Handle with low toggle

03.622.002 Pangea Footed Screwdriver Shaft

03.622.015* Pangea Footed Screwdriver with T-Handle

03.622.032* Pangea Footed Screwdriver Shaft, short

03.622.033* Holding Sleeve, for Pangea FootedScrewdriver Shaft, short

2bInsert Pangea polyaxial screw

Instruments

03.620.001 StarDrive Screwdriver, T25, with T-Handle

03.620.003 StarDrive Screwdriver Shaft, T25, 6 mm hexcoupling

03.620.005 Ratchet T-Handle with low toggle

03.620.006 StarDrive Screwdriver, T25, with straighthandle

Use the StarDrive Screwdriver to select a polyaxial screw fromthe screw rack. Place the self-retaining screwdriver tip firmlyinto the star recess and pick up the screw.

Insert the screw into the prepared pedicle.

Repeat for each screw.

*Also available

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Screw Insertion continued

8 Synthes Spine Pangea System

2bInsert Pangea polyaxial screw continued

Alternative 1: Pangea Stabilization Sleeve

Instruments

03.620.004 Pangea Stabilization Sleeve

03.620.006 StarDrive Screwdriver, T25, with straight handle

If there is soft tissue in the path accessing the pedicle, thePangea Stabilization Sleeve may be used to stabilize thescrew head and keep it from rotating during insertion.

Load the Stabilization Sleeve onto the StarDrive Screwdriver.Place the screwdriver tip firmly into the star recess of thescrew in the screw rack and slide the stabilization sleevedown into the screw head.

The sleeve should be held during screw insertion to preventthe head from turning as the screw advances.

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Synthes Spine 9

Alternative 2: Pangea Retaining Sleeve

Instruments

03.620.006 StarDrive Screwdriver, T25, with straight handle

03.620.023 Pangea Retaining Sleeve

If it is necessary to exert lateral forces on the screw during insertion, the Pangea Retaining Sleeve provides rigid couplingto keep the screw secure.

To assemble, press and hold down the assembly button whilesliding the sleeve toward the handle until it stops (Figure 1).Then push the outer knurled sleeve toward the handle (Figure2). Ensure that the tensioning knob is loosened (Figure 3).

Place the screwdriver tip firmly into the StarDrive recess ofthe screw in the screw rack, and turn the retaining sleeve to align the tips with the rod slot.

Push the outer sleeve down to capture and pick up the screw.

After the screw is loaded, the tensioning knob may be tight-ened to apply more retaining force on the screw (Figure 4).

Tensioning knob

Assembly button

Figure 1

Figure 2

Figure 3

Figure 4

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Screw Insertion continued

10 Synthes Spine Pangea System

Alternative 2: Pangea Retaining Sleeve continued

Insert the Pangea screw into the prepared pedicle. The outersleeve may be held during screw insertion.

Note: Do not press the assembly button during screw insertion. If the assembly button is accidentally pressed whilethe screw is loaded, the red indicator line will be visible onthe sleeve. If this happens, pull up the outer sleeve and pushit back down to reload the screw.

To release the sleeve, pull up on the outer sleeve and removethe screwdriver. Repeat for each screw.

3Confirm implant position

Position of the implants should be confirmed radiographically.

2bInsert Pangea polyaxial screw continued

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Hook Placement

Synthes Spine 11

4aPrepare lamina for a lamina hook

Instruments

03.622.020 Extra Small Lamina Finder

388.104 Small Lamina Finder

388.105 Medium Lamina Finder

388.106 Large Lamina Finder

Using the appropriate size lamina finder, separate the ligamentum flavum from the underside of the lamina to ensure good bony contact with the lamina hook.

4bPrepare pedicle for a pedicle hook

Instrument

03.622.012 Pedicle Finder

Using the Pedicle Finder, open the facet capsule and locatethe pedicle.

Remove a small piece of the inferior articular process to ensure proper seating of the pedicle hook. Pedicle hooksshould be placed in an up-going direction only.

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12 Synthes Spine Pangea System

4cPrepare transverse process for transverse process hook

Instrument

03.622.030 Transverse Process Finder

Use the Transverse Process Finder to separate the ligamen-tum flavum from the undersurface of the transverse process.

5Place hook

Instruments

03.622.040 Pangea Hook Holding Forceps, lateral

03.622.041 Pangea Hook Holding Forceps, straight

03.622.042 Pangea Hook Holding Forceps, curved

388.110 Hook Positioner

Attach the hook to the appropriate Pangea Hook HoldingForceps. Place the hook in the desired location. The Hook Positioner may also be used to facilitate placement of thehook.

6Place remaining hooks

Repeat steps 4 and 5 to place hooks as determined in thepreoperative plan.

Hook Placement continued

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Rod Contouring

Synthes Spine 13

7Determine rod contour and length

Instruments

388.902 6.0 mm Coated Rod Template, 150 mm

388.905 6.0 mm Coated Rod Template, 500 mm

To determine the contour of the rod, use the 6.0 mm CoatedRod Template. Cut the rod to length, as needed.

8Contour the rod

Instruments

03.620.020 Rod Bender with radius adjustment andspring opening

03.622.060* Pipe Benders, with long handles

388.112 In Situ Bender, right and left388.113

Contour the rod to match the rod template using the RodBender. Alternatively, the In Situ Benders or Pipe Bendersmay be used to contour the rod.

*Also available

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Rod Reduction and Construct Assembly

14 Synthes Spine Pangea System

9Align rod to hooks and screws

Instrument

03.622.081 Rod Holders with Clamp Grip

Use the Rod Holders with Clamp Grip to insert the rod intothe openings of the top-loading screws or hooks. If neces-sary, use the following instruments to aid reduction:

Option 1: Rod Pusher

Instrument

388.114 Rod Pusher

Seat the rod into the screw or hook using the Rod Pusher.

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Synthes Spine 15

Option 2: Rocker Forks

Instruments

03.620.009 Pangea Small Rocker Fork, with straight shaft

03.620.010 Pangea Small Rocker Fork, with curved shaft

03.622.055 Pangea Medium Rocker Fork, with curved shaft

Use a Pangea Rocker Fork as a lever to seat the rod into theimplant opening.

Option 3: Vertical Reducer

Instrument

03.622.095 Pangea Vertical Reducer

Before placing the Pangea Vertical Reducer over the implanthead, ensure that the ratchet handle is fully open. Place thevertical reducer over the implant head and squeeze the handleto seat the rod.

Note: The knob should be loosened and the tube retractedfor cleaning and sterilization.

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Rod Reduction and Construct Assembly continued

9Align rod to hooks and screws

Option 4: Bi-Planar Persuader

Instruments

03.622.090 Bi-Planar Persuader

03.622.091 Implant Holder, for Bi-Planar Persuader

Use the Bi-Planar Persuader and ImplantHolder in situations where the rod is lateral to and/or above the implantopening.

Note: The sleeve and Implant Holdershould be disassembled prior to cleaningand sterilization.

Assemble Implant Holder Slide the sleeve onto the Implant Holderso that the ball detents on the sleevesnap into the groove on the ImplantHolder. This is the “UP” position of thesleeve on the Implant Holder.

Attach ImplantAttach the Implant Holder to the side ofthe screw or hook by snapping it ontothe mating features on the side of theimplant. Use a rolling action to first snapon one side of the implant and then theother side. Slide the sleeve down until it stops.

16 Synthes Spine Pangea System

Bi-Planar Persuader

Ratchetinghandle

Directionalswitch

Directionalknob

Approximatingarms

Implant Holder

Sleeve for Implant Holder

Assembled Implant Holder

continued

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Synthes Spine 17

DownTo move the Persuader downward, flipthe directional switch to the “D” or“DOWN” position. Rotate the direc-tional knob counterclockwise.

Engage RodPlace the Bi-Planar Persuader over theImplant Holder. Ensure that the direc-tional switch is in the “DOWN” position.

Turn the silver directional knob to movethe Persuader along the ImplantHolder.

UpTo move the Persuader upward, flip thedirectional switch to the “U” or “UP”position. Rotate the directional knobclockwise.

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Rod Reduction and Construct Assembly continued

9Align rod to hooks and screws continued

Option 4: Bi-Planar Persuader continued

Engage the rod with the approximating arms and squeezethe ratcheting handle to position the rod above the implantopening. Rotate the directional knob to fully seat the rodwithin the implant opening.

The approximating arms can also be used to pull the rod upand over the side of the implant.

When using the Bi-Planar Persuader to reduce the rod, theapproximating arms will serve as a guide for the locking capscrewdriver.

10Insert locking caps

Instruments

03.620.001 StarDrive Screwdriver, T25, with T-Handle

03.620.006 StarDrive Screwdriver, T25, with straight handle

Insert the StarDrive Screwdriver tip firmly into a Pangea Lock-ing Cap and remove the cap from the graphic case. Align theblack etching on the locking cap with the rod.

When the cap is in the correct position, it will drop slightlyinto the Pangea implant head. Push down on the cap tosnap it into the Pangea head. Turn the locking cap a quarterturn until the cap stops. The cap will snap into this position.When the locking cap is fully engaged, the black etching willbe perpendicular to the rod.

18 Synthes Spine Pangea System

Position of etch markon locking cap

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If provisional tightening is desired, turn the screwdriver furtherto drive the setscrew down and lock the rod.

To remove the Bi-Planar Persuader and Implant Holder, release the ratcheting handle so that the approximating armsdisengage from the rod. Slide the sleeve up the ImplantHolder and release the persuader from the implant.

Synthes Spine 19

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Rod Reduction and Construct Assembly continued

10Insert locking caps continued

Option: Locking Cap Driver (if the setscrew turns freely within the cap)

Instruments

03.620.006 StarDrive Screwdriver, T25, with straight handle

03.620.013 Pangea Locking Cap Driver with T-Handle

Slide the Pangea Locking Cap Driver over the StarDriveScrewdriver to the top groove. Thread the Pangea LockingCap Driver clockwise onto the top of the setscrew until it issnug. Turn the Pangea Locking Cap Driver clockwise to rotate the cap one quarter turn.

20 Synthes Spine Pangea System

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Notes:It is possible to visually identify locking caps that have hadtheir initial preload disturbed by examining the alignment ofthe setscrew to the cap.

If the etch marks are not aligned, the setscrew is not ready tocarry the cap through the quarter turn. The locking cap driveroption should be used in this situation.

11Remove rod reduction instrument

Remove the rod reduction instrument after the locking cap is inserted.

Synthes Spine 21

Set Not set

Important: Unthread the Pangea Locking Cap Driver counterclockwise (while holding onto screwdriver handle)and retract it before driving the setscrew further with theStarDrive Screwdriver.

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Deformity Correction

Deformity correction can be assisted by additional manipula-tion of the construct.

In Situ bending

Instruments

03.622.062 Coronal Rod Benders, right and left03.622.061

388.112 In Situ Benders, right and left388.113

Use the In Situ Benders, right and left, to contour the rod inthe sagittal plane and the Coronal Rod Benders, right andleft, to contour the rod in the coronal plane.

Rod rotationIf rod rotation is desired, the following options may be used.Ensure that the locking cap setscrews are not tightened during rod rotation.

Option 1: Rod Holding Forceps with Clamp Grip

Instruments

03.620.006 StarDrive Screwdriver, T25, with straight handle

03.622.081 Rod Holding Forceps with Clamp Grip

Use the Rod Holding Forceps to grasp the rod and slowly ro-tate it in the proper direction. Use the StarDrive Screwdriver totighten the setscrews after achieving the desired rod rotation.

22 Synthes Spine Pangea System

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Option 2: Hex-end Rods and Rod Rotation Wrench

Instruments

03.620.006 StarDrive Screwdriver, T25, with straight handle

03.622.084 Rod Rotation Wrench, angled

If hex-end rods are used in the construct, the Rod RotationWrench can be applied to the end of the rod containing thehex and rotated. Use the StarDrive Screwdriver to tighten thesetscrews after achieving the desired rod rotation.

Derotation

Instrument

03.622.007 Pangea Derotation Instrument

If a derotation maneuver is desired, ensure that the lockingcap setscrews are not tightened.

Place a Pangea Derotation Instrument (tube) over each selected screw. Use the tubes as leverage to maneuver thevertebral bodies. Insert the StarDrive Screwdriver through the tubes to tighten the setscrews.

Synthes Spine 23

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Distraction and Compression

If distraction is required

Instruments

03.620.006 StarDrive Screwdriver, T25, with straight handle

03.622.071 Parallel Distractor, for 6.0 mm rods

03.622.081 Rod Holding Forceps with Clamp Grip

Use the Rod Holding Forceps as a point of fixation againstwhich to distract.

Use the Parallel Distractor for 6.0 mm rods to distract the construct. Once in the desired position, tighten the setscrewsof the locking caps with the StarDrive Screwdriver.

24 Synthes Spine Pangea System

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If compression is required

Instruments

03.620.006 StarDrive Screwdriver, T25, with straight handle

03.622.006* Parallel Compressor with Extended Travel

03.622.070 Parallel Compressor, for 6.0 mm rods

03.622.081 Rod Holding Forceps with Clamp Grip

Use the Rod Holding Forceps as a point of fixation againstwhich to compress.

Use the Parallel Compressor for 6.0 mm rods to compressthe construct. Once in the desired position, tighten thesetscrews of the locking caps with the StarDrive Screwdriver.

Synthes Spine 25

*Also available

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Final Tightening

Instruments

03.622.018 Countertorque, for T25 StarDrive Screwdriver

03.620.019 10 Nm Torque Limiting Handle

03.620.022 StarDrive Screwdriver Shaft, T25, short

Place the Countertorque over the screw or hook head. Attach the StarDrive Screwdriver Shaft to the 10 Nm TorqueLimiting Handle and insert the shaft through the Counter-torque and into the locking cap setscrew. Tighten until theTorque Limiting Handle clicks, which indicates that 10 Nm oftorque has been applied.

Repeat for all locking caps.

26 Synthes Spine Pangea System

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Optional Surgical Technique—Transconnector Attachment

Instruments

03.620.021 Transconnector Template

388.395 2.5 mm Hexagonal Screwdriver, long

The Low Profile Transconnector is used to stabilize the con-struct and to increase rotational stability.

Use the Transconnector Template to measure the distancebetween the two rods.

Choose a transconnector of the appropriate length. Ensurethat the transconnector setscrews are not advanced. Applythe transconnector to the rods. Use the 2.5 mm HexagonalScrewdriver to secure the transconnector to the rods bytightening the setscrews on each end.

For a transconnector with angular adjustment, tighten thestargrind setscrew to lock the angle between the rods.

To adjust the length of the transconnector, slide the ends tothe appropriate length and tighten the center setscrew.

Note: If any part of the construct requires further adjust-ment, all transconnector setscrews must be loosened. Afterfinal adjustment, retighten all the setscrews.

Synthes Spine 27

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Optional Surgical Technique—Transverse Bar Attachment

The transverse bar provides an extension to the hook ormonoaxial screw in situations where the rod contour or patient anatomy prevents a direct hook- or screw-to-rod connection. The bar lengths are 15 mm, 20 mm, 25 mm and 30 mm.

Instruments

388.114 Rod Pusher

388.395 2.5 mm Hexagonal Screwdriver, long

Place the opening of the transverse bar over the 6.0 mm rod.Loosely attach the transverse bar to the rod by tightening thesetscrew with the 2.5 mm Hexagonal Screwdriver.

Introduce the transverse bar into the screw or transversehook opening. Use the Rod Pusher if necessary.

Secure the transverse bar to the hook or screw by insertingthe locking cap and tightening the setscrew.

Secure the transverse bar to the rod by tightening thesetscrew firmly.

28 Synthes Spine Pangea System

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Implants

Pangea Screws

Dual Core Thread Design – Constant outer diameter optimizes pull-out strength

– Core diameter transitions to provide cancellous and cortical bone-specific threads

– Cortical threads engage the pedicle

– Cancellous threads engage the vertebral body

Other Features– Top-loading/tightening for easy rod introduction

– Rounded tip promotes safe screw insertion

– Self-tapping tip

– Double-lead thread on 4.0 mm–7.0 mm screws for easy insertion

– Color-coded by diameter

Monoaxial Screws– Low profile of 11.5 mm

– Screw opening accommodates bent rod

– Screw head contains features that mate with rod reduction instruments

Polyaxial Screws– Polyaxial head offers 25° of angulation about the axis of the

screw allowing the implant to adjust readily to the rod

– Rod snaps into head to stabilize construct before lockingcap installation

– Screw head contains features that mate with rod reduction instruments

Synthes Spine 29

Reduction featurefor lateral attachment

1.3 mm space to accommodatebent rod

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Implants continued

*Also available

30 Synthes Spine Pangea System

Pangea Hooks

– Multiple hook geometries for use around the lamina, pedicle, or transverse process

– Low-profile design minimizes soft tissue interference

– Specialized lamina hooks for thoracic and lumbar applications

– Color-coded by size

Locking Cap

– Quarter-turn rod capture

– Rod-gripping ridges

– Self-aligning saddle

– Simple alignment cues

Visual markings

Tactile feedback for insertion and quarter-turn engagement

Low-Profile Transconnectors

– Used as construct stabilizer to reduce rotation

– Preassembled for ease of placement

– Four fixed lengths and eight adjustable lengths

Transverse Bars

– Provide a lateral extension from the 6.0 mm rod to thescrew or transverse hook

– Lengths of 15 mm, 20 mm, 25 mm and 30 mm

– Eliminate the need for severe rod contours which mightotherwise be required for direct hook- or screw-to-rodconnection

6.0 mm Rods

– Available in titanium and titanium alloy (Ti-6Al-7Nb)

– Standard straight rods

– Hex-end rods aid in rod rotation

– Precontoured rods reduce intra operative rod bending*

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Pangea Hooks

Synthes Spine 31

Implant Placement Sizes Blade direction(Up–Down)

Description

Pedicle Hook Articular Process S M Up Bifid blade tip grips the pedi-cle for secure hook placement

Lamina Hook Lamina XS S M L Up Down Multiple hook sizes fit variedpatient anatomies

Tall Body Lamina Hook Lamina XS S M L Up Down Increased body height easesrod reduction in the dorso-ventral plane

Down-Angled Lamina Hook

Lamina M Up Specialty hook designed for optimal fit in the lumbar lamina

Up-Angled Lamina Hook

Lamina M Down Up-angled hook is placed in a downward direction on the lamina

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Implants continued

32 Synthes Spine Pangea System

Pangea Hooks continued

Implant Placement Sizes Blade direction(Up–Down)

Description

Thoracic Lamina Hook Lamina M Up Down Small hook blade is optimal inthoracic spine

Offset Lamina Hook

Lamina M Up Down Eases rod reduction when rodis not aligned with the hook.Offset lamina hooks are alsoavailable with up- or down-angled hook blades.

Transverse Process Hook

Transverse Process M Up Down Left and right transverseprocess hooks offer anglessuited for ideal fit on transverse processes

Page 34: PangeaSystem. For deformity correction.synthes.vo.llnwd.net/o16/Mobile/Synthes North America/Product Sup… · Low Profile. Indications The Pangea Deformity Correction System consists

Instruments

388.536 Pedicle Probe with Palm Handle, for 4.0 mmand 4.2 mm screws

3.0 mm width at tip

388.655 Probe with Palm Handle

3.7 mm width at tip

03.622.005 Thoracic Pedicle Probe

3.0 mm width at tip

388.545 Straight Ball Tip Probe

388.546 Curved Ball Tip Probe

Synthes Spine 33

For Deformity Preparation

388.656 Awl with Palm Handle

4 mm tip diameter

388.657 Curved Probe with Palm Handle

3.7 mm width at tip

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Instruments continued

34 Synthes Spine Pangea System

03.622.004 Pangea Footed Screwdriver with StraightHandle

03.622.002 Pangea Footed Screwdriver Shaft, 6 mm hex coupling

For Monoaxial Screws

03.622.008 Pangea Monoaxial Screw Alignment Tool

03.622.003 Pangea Holding Sleeve, for footedscrewdrivers

03.622.015* Pangea Footed Screwdriver with T-Handle

*Also available

For Deformity Preparation continued

Taps, 6 mm hex coupling03.620.104 For 4.0 mm Dual Core Screws03.620.105 For 5.0 mm Dual Core Screws03.620.106 For 6.0 mm Dual Core Screws03.620.107 For 7.0 mm Dual Core Screws03.620.108 For 8.0 mm Dual Core Screws03.620.109 For 9.0 mm Dual Core Screws

03.620.005 Ratchet T-Handle with low toggle

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Synthes Spine 35

03.620.001 StarDrive Screwdriver, T25, with T-handle

03.620.006 StarDrive Screwdriver, T25, with straight handle

03.620.003 StarDrive Screwdriver Shaft, T25, 6 mm hex coupling

03.620.005 Ratchet T-Handle with low toggle, 6 mm hex coupling

For Polyaxial Screws and Locking Caps

03.620.013 Pangea Locking Cap Driver with T-Handle

03.620.100 Ratchet Straight Handle with low toggle,6 mm hex coupling

03.622.016* Pangea Locking Cap Driver with Knurled Handle

*Also available

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Instruments continued

36 Synthes Spine Pangea System

For Polyaxial Screws and Locking Caps continued

03.622.012 Pedicle Finder

Lamina Finders03.622.020 Extra small388.104 Small388.105 Medium388.106 Large

For Hook Preparation

03.622.030 Transverse Process Finder

03.620.014 Pangea Remobilization Tool

03.620.023 Pangea Retaining Sleeve

03.620.004 Pangea Stabilization Sleeve

03.622.020

Page 38: PangeaSystem. For deformity correction.synthes.vo.llnwd.net/o16/Mobile/Synthes North America/Product Sup… · Low Profile. Indications The Pangea Deformity Correction System consists

03.620.020 Rod Bender with radius adjustment andspring opening

03.622.060* Pipe Benders, with long handles

Synthes Spine 37

For Rod Contouring

03.622.042 Pangea Hook Holding Forceps, curved

388.110 Hook Positioner

Coated Rod Templates, for 6.0 mm rods388.902 150 mm388.905 500 mm

For Hook Placement

03.622.040 Pangea Hook Holding Forceps, lateral

03.622.041 Pangea Hook Holding Forceps, straight

*Also available

Page 39: PangeaSystem. For deformity correction.synthes.vo.llnwd.net/o16/Mobile/Synthes North America/Product Sup… · Low Profile. Indications The Pangea Deformity Correction System consists

Instruments continued

38 Synthes Spine Pangea System

For Construct Assembly

03.622.081 Rod Holding Forceps with Clamp Grip

328.028 Rod Holding Forceps, straight

03.620.009 Pangea Small Rocker Fork, with straight shaft

For Rod Reduction

03.622.095 Pangea Vertical Reducer

03.620.010 Pangea Small Rocker Fork, with curved shaft

03.622.055 Pangea Medium Rocker Fork, with curved shaft

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Synthes Spine 39

03.622.090 Bi-Planar Persuader, for Pangea

03.622.091 Implant Holder, for Bi-Planar Persuader

388.114 Rod Pusher

03.622.061 Coronal Rod Bender, left, for 6.0 mm rods03.622.062 Coronal Rod Bender, right, for 6.0 mm rods

For Deformity Correction

388.112 In Situ Bender, right388.113 In Situ Bender, left

03.620.011 Pangea Rod Pusher, countertorque

Page 41: PangeaSystem. For deformity correction.synthes.vo.llnwd.net/o16/Mobile/Synthes North America/Product Sup… · Low Profile. Indications The Pangea Deformity Correction System consists

Instruments continued

40 Synthes Spine Pangea System

03.622.070 Parallel Compressor, for 6.0 mm rods

03.622.071 Parallel Distractor, for 6.0 mm rods

03.622.006* Parallel Compressor with Extended Travel

For Distraction and Compression

For Deformity Correction continued

03.622.007 Pangea Derotation Instrument

*Also available

03.622.084 Rod Rotation Wrench, angled, for 6.0 mmhex-end rods

03.622.081 Rod Holding Forceps with Clamp Grip

Page 42: PangeaSystem. For deformity correction.synthes.vo.llnwd.net/o16/Mobile/Synthes North America/Product Sup… · Low Profile. Indications The Pangea Deformity Correction System consists

03.620.022 StarDrive Screwdriver Shaft, T25, 6 mm hexcoupling, short

Synthes Spine 41

For Final Tightening

For Transconnector

03.620.019 10 Nm Torque Limiting Handle, 6 mm hex coupling

388.395 2.5 mm Hexagonal Screwdriver, long

03.620.021 Transconnector Template

03.622.018 Countertorque, for StarDrive Screwdrivers, T25

03.622.081 Rod Holding Forceps with Clamp Grip

Page 43: PangeaSystem. For deformity correction.synthes.vo.llnwd.net/o16/Mobile/Synthes North America/Product Sup… · Low Profile. Indications The Pangea Deformity Correction System consists

Pangea Deformity Instrument and Titanium Monoaxial Screw Set(01.622.420)

42 Synthes Spine Pangea System

Sterilization Parameters for Sets (01.622.300, 01.622.310,01.622.320, 01.622.330, 01.622.410, 01.622.420, 01.622.430,01.622.440, 01.622.450)These Synthes sets with all additionally available items, as marked in the case,can be sterilized by the following parameters. For more information, please referto graphic case package insert.

Method Cycle Temperature Exposure Time

Steam Prevacuum 132°–135°C 10 Minutes(Wrapped) (270°–275°F) (20 Minute Dry time)

Steam Gravity Displacement 132°–135°C 28 Minutes(Wrapped) (270°–275°F) (20 Minute Dry time)

Graphic Case60.622.420 Graphic Case for Pangea Titanium Monoaxial

Screws and Instruments

Implants

4.0 mm Titanium PangeaMonoaxial Pedicle Screws

ThreadLength (mm) Qty.

04.622.420 20 4

04.622.425 25 8

04.622.428 28 4

04.622.430 30 8

04.622.432 32 4

04.622.435 35 8

04.622.438 38 4

04.622.440 40 6

04.622.445 45 4

5.0 mm Titanium PangeaMonoaxial Pedicle Screws

ThreadLength (mm) Qty.

04.622.525 25 6

04.622.530 30 8

04.622.535 35 8

04.622.540 40 8

04.622.545 45 8

04.622.550 50 4

04.622.555 55 4

6.0 mm Titanium PangeaMonoaxial Pedicle Screws

04.622.625 25 2

04.622.630 30 4

04.622.635 35 6

04.622.640 40 8

04.622.645 45 8

04.622.650 50 6

04.622.655 55 4

04.622.660 60 4

04.622.665 65 4

8.0 mm Titanium PangeaMonoaxial Pedicle Screws

04.622.825 25 2

04.622.830 30 2

04.622.835 35 2

04.622.840 40 2

04.622.845 45 2

04.622.850 50 2

04.622.855 55 2

04.622.860 60 2

04.622.865 65 2

7.0 mm Titanium PangeaMonoaxial Pedicle Screws

04.622.725 25 2

04.622.730 30 4

04.622.735 35 6

04.622.740 40 8

04.622.745 45 8

04.622.750 50 4

04.622.755 55 2

04.622.760 60 2

04.622.765 65 2

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Synthes Spine 43

Implants continued

04.620.000 Titanium Pangea Locking Cap, 40 ea.

6.0 mm Titanium Transverse Bars, 2 ea.

Instruments03.622.003 Pangea Holding Sleeve, for Footed Screw-

drivers, 2 ea. 03.622.004 Pangea Footed Screwdriver with Straight

Handle, 2 ea. 03.622.008 Pangea Monoaxial Screw Alignment Tool

Length (mm)499.450 15

499.451 20

Length (mm)499.452 25

499.453 30

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44 Synthes Spine Pangea System

Pangea Hook Instrument and Titanium Implant Set (01.622.410)

Graphic Case60.622.410 Graphic Case for Pangea Titanium Hooks and

Instruments

Titanium Implants04.622.010 Extra Small Lamina Hook, 4 ea.

04.622.011 Small Lamina Hook, 4 ea.

04.622.012 Medium Lamina Hook, 8 ea.

04.622.013 Large Lamina Hook, 6 ea.

04.622.018 Thoracic Lamina Hook, 4 ea.

04.622.020 Extra Small Tall Body Lamina Hook, 2 ea.

04.622.021 Small Tall Body Lamina Hook, 2 ea.

04.622.022 Medium Tall Body Lamina Hook, 2 ea.

04.622.023 Large Tall Body Lamina Hook, 2 ea.

04.622.101 Small Pedicle Hook, 6 ea.

04.622.102 Medium Pedicle Hook, 8 ea.

04.622.110 Transverse Process Hook, right, 4 ea.

04.622.111 Transverse Process Hook, left, 4 ea.

04.622.120 Lamina Hook, offset right, 2 ea.

04.622.121 Lamina Hook, offset left, 2 ea.

04.622.130 Up-Angled Lamina Hook, offset right, 2 ea.

04.622.131 Up-Angled Lamina Hook, offset left, 2 ea.

04.622.132 Up-Angled Lamina Hook, 2 ea.

04.622.140 Down-Angled Lamina Hook, offset right, 2 ea.

04.622.141 Down-Angled Lamina Hook, offset left, 2 ea.

04.622.142 Down-Angled Lamina Hook, 4 ea.

04.622.200 Extra Small Lamina Hook, transverse

04.622.201 Small Lamina Hook, transverse

04.622.202 Medium Lamina Hook, transverse

04.622.203 Large Lamina Hook, transverse

04.622.208 Thoracic Lamina Hook, transverse

04.622.220 Extra Small Tall Body Lamina Hook, transverse

04.622.221 Small Tall Body Lamina Hook, transverse

04.622.222 Medium Tall Body Lamina Hook, transverse

04.622.223 Large Tall Body Lamina Hook, transverse

04.622.301 Small Pedicle Hook, transverse

04.622.302 Medium Pedicle Hook, transverse

04.622.310 Transverse Process Hook, transverse right

04.622.311 Transverse Process Hook, transverse left

04.622.312 Angled Lamina Hook, transverse

Instruments03.622.012 Pedicle Finder

03.622.020 Extra Small Lamina Finder

388.104 Small Lamina Finder

388.105 Medium Lamina Finder

388.106 Large Lamina Finder

03.622.030 Transverse Process Finder

03.622.040 Hook Holding Forceps, lateral

03.622.041 Hook Holding Forceps, straight, 2 ea.

03.622.042 Hook Holding Forceps, curved

388.110 Hook Positioner

Page 46: PangeaSystem. For deformity correction.synthes.vo.llnwd.net/o16/Mobile/Synthes North America/Product Sup… · Low Profile. Indications The Pangea Deformity Correction System consists

Titanium Pangea Deformity Rod and Transconnector Implant Set (01.622.430)

Graphic Case60.622.430 Graphic Case, for Titanium Pangea Deformity

Rod and Transconnector Implants

Implants6.0 mm Titanium Hard Rods, 2 ea.

498.108 200 mm

498.112 300 mm

498.116 400 mm

498.119 500 mm

04.622.317 6.0 mm Titanium Hexagonal-End Rod,500 mm, 2 ea.

Titanium Low Profile Transconnectors, for 6.0 mm rods

Length (mm) Qty.

497.791 15 2

497.792 18 2

497.793 21 3

497.794 24 3

497.795 25.5–30.5 4

497.796 31.5–34 4

04.620.203 33–36.5 4

497.797 35–41 4

04.620.204 38.5–48 4

497.798 42–55 4

04.620.205 49–69 4

497.799 56–83 2

Instrument03.620.021 Measuring Template for Transconnectors

Synthes Spine 45

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46 Synthes Spine Pangea System

Pangea Basic Instrument Set (01.622.300)

Graphic Case690.243 Graphic Case, for Pangea Basic Instruments

Instruments03.620.001 StarDrive Screwdriver, T25, with T-Handle

03.620.003 StarDrive Screwdriver Shaft, T25, 6 mm hexcoupling, 2 ea.

03.620.004 Pangea Stabilization Sleeve, 2 ea.

03.620.005 Ratchet T-Handle with low toggle, 6 mm hex coupling, 2 ea.

03.620.006 StarDrive Screwdriver, T25, with straighthandle, 2 ea.

03.620.009 Pangea Small Rocker Fork, with straight shaft

03.620.010 Pangea Small Rocker Fork, with curved shaft

03.620.011 Pangea Rod Pusher, countertorque, 2 ea.

03.620.013 Pangea Locking Cap Driver with T-Handle, 2 ea.

03.620.019 10 Nm Torque Limiting Handle, 6 mm hexcoupling

03.620.022 StarDrive Screwdriver Shaft, T25, 6 mm hexcoupling, short, 2 ea.

03.620.023 Pangea Retaining Sleeve, 2 ea.

328.028 Rod Holding Forceps, straight

388.114 Rod Pusher

388.395 2.5 mm Hexagonal Screwdriver, long

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Pangea Deformity Preparation Instrument Set (01.622.310)

Graphic Case60.622.310 Graphic Case, for Pangea Deformity

Preparation Instruments

InstrumentsTaps, 180 mm, 6 mm hex coupling

03.620.104 For 4.0 mm Dual Core Screws

03.620.105 For 5.0 mm Dual Core Screws

03.620.106 For 6.0 mm Dual Core Screws

03.620.107 For 7.0 mm Dual Core Screws

03.620.108 For 8.0 mm Dual Core Screws

03.620.109 For 9.0 mm Dual Core Screws

03.622.005 Thoracic Pedicle Probe

388.536 Pedicle Probe with Palm Handle, for 4.0 mm/4.2 mm Screws

388.545 Straight Ball Tip Probe

388.546 Curved Ball Tip Probe

388.655 Probe with Palm Handle

388.656 Awl with Palm Handle

388.657 Curved Probe with Palm Handle

Synthes Spine 47

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48 Synthes Spine Pangea Deformity Correction System

Pangea Deformity Rod Instrument Set (01.622.320)

Graphic Case60.622.320 Graphic Case, for Pangea Deformity Rod

Instruments

Instruments03.620.020 Rod Bender with radius adjustment

03.622.061 Coronal Rod Bender, left, for 6.0 mm rods

03.622.062 Coronal Rod Bender, right, for 6.0 mm rods

03.622.070 Parallel Compressor, for 6.0 mm rods

03.622.071 Parallel Distractor, for 6.0 mm rods

03.622.081 Rod Holding Forceps with Clamp Grip, 2 ea.

03.622.084 Rod Rotation Wrench, angled, for 6.0 mm hex-end rods

03.622.095 Pangea Vertical Reducer

388.112 In Situ Bender, right

388.113 In Situ Bender, left

Coated Rod Templates, for 6.0 mm Rods

388.902 150 mm

388.905 500 mm

Page 50: PangeaSystem. For deformity correction.synthes.vo.llnwd.net/o16/Mobile/Synthes North America/Product Sup… · Low Profile. Indications The Pangea Deformity Correction System consists

Pangea Deformity Correction Instrument Set (01.622.330)

Synthes Spine 49

Graphic Case60.622.330 Graphic Case for Deformity Correction

Instruments

Instruments03.620.014 Pangea Remobilization Tool

03.622.002 Pangea Footed Screwdriver Shaft, 6 mm hexcoupling, 2 ea.

03.622.007 Pangea Derotation Instrument, 4 ea.

03.622.018 Countertorque, for StarDrive Screwdrivers, T25

03.622.055 Pangea Medium Rocker Fork, with curvedshaft

03.622.090 Bi-Planar Persuader, for Pangea, 2 ea.

03.622.091 Implant Holder, for Bi-Planar Persuader, 2 ea.

Page 51: PangeaSystem. For deformity correction.synthes.vo.llnwd.net/o16/Mobile/Synthes North America/Product Sup… · Low Profile. Indications The Pangea Deformity Correction System consists

Also Available

50 Synthes Spine Pangea System

Titanium Pangea Deformity Auxiliary Monoaxial ScrewSet (01.622.440)60.622.440 Graphic Case for Titanium Pangea Monoaxial

Auxiliary Screws

Titanium Pangea Monoaxial Pedicle Screws, dual core

Titanium Pangea Polyaxial Screw Implant Set(01.622.450)690.234 Graphic Case, for Titanium Pangea Polyaxial

Screws

Titanium Pangea Polyaxial Pedicle Screws, dual core, withStarDrive T25 recess

ThreadLength

7.0 mm dia. (mm) Qty.

04.620.730 30 4

04.620.735 35 4

04.620.740 40 8

04.620.745 45 8

04.620.750 50 6

04.620.755 55 4

8.0 mm dia.04.620.830 30 2

04.620.835 35 4

04.620.840 40 4

04.620.845 45 4

04.620.850 50 4

04.620.855 55 2

ThreadLength

7.0 mm dia. (mm) Qty.04.622.770 70 4

04.622.775 75 4

04.622.780 80 4

04.622.790 90 4

04.622.799 100 4

8.0 mm dia.04.622.870 70 4

04.622.875 75 4

04.622.880 80 4

04.622.890 90 4

04.622.899 100 4

9.0 mm dia.04.622.930 30 2

04.622.935 35 2

04.622.940 40 2

04.622.945 45 2

04.622.950 50 2

04.622.955 55 2

04.622.960 60 2

04.622.965 65 2

04.622.970 70 2

04.622.975 75 2

04.622.980 80 2

04.622.990 90 2

04.622.999 100 2

ThreadLength

4.0 mm dia. (mm) Qty.04.620.420 20 4

04.620.425 25 8

04.620.428 28 4

04.620.430 30 8

04.620.432 32 4

04.620.435 35 8

04.620.438 38 4

04.620.440 40 4

04.620.445 45 4

5.0 mm dia.04.620.530 30 6

04.620.535 35 6

04.620.540 40 6

04.620.545 45 6

04.620.550 50 4

6.0 mm dia.04.620.630 30 4

04.620.635 35 8

04.620.640 40 12

04.620.645 45 12

04.620.650 50 8

04.620.655 55 4

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Implants6.0 mm Titanium Hexagonal-End Rods

Length (mm)

04.622.314 200

04.622.315 300

04.622.316 400

04.622.352* 200

04.622.353* 300

04.622.354* 400

04.622.355* 500

6.0 mm Titanium Precontoured Rods, 400 mm length

Straight section (mm)

04.600.014 50

04.600.016 65

04.600.018 80

Instruments03.620.015 Polyaxial Head Positioner

03.620.026 Pangea Cap Introducer

03.620.100 Ratchet Straight Handle with low toggle, 6 mm hex coupling

03.622.006 Parallel Compressor with Extended Travel03.622.015 Pangea Footed Screwdriver with T-Handle

03.622.016 Pangea Locking Cap Driver with Knurled Handle

03.622.032 Pangea Footed Screwdriver Shaft, short

03.622.033 Holding Sleeve for Pangea FootedScrewdriver Shaft, short

03.622.060 Pipe Benders, with long handles (2/pkg.)

03.622.096 Pangea Vertical Reducer, long

Modules and Screw Racks60.622.411 Module for Titanium Pangea Hooks

60.622.412 Module for Titanium Pangea Specialty Hooks

60.622.421 Screw Rack, for Titanium Pangea MonoaxialScrews

60.622.422 Module, for Titanium Transverse Bars

60.622.431 Module, for Titanium Transconnectors

690.241 Module, for Pangea Locking Caps

Synthes Spine 51

ThreadLength

6.0 mm dia. (mm) Qty.04.620.665 65 4

7.0 mm dia.04.620.765 65 4

04.620.770 70 4

04.620.775 75 4

04.620.780 80 4

04.620.790 90 4

04.620.799 100 4

8.0 mm dia.04.620.865 65 2

04.620.870 70 4

04.620.875 75 4

04.620.880 80 4

04.620.890 90 4

04.620.899 100 4

ThreadLength

9.0 mm dia. (mm) Qty.04.620.930 30 4

04.620.935 35 4

04.620.940 40 8

04.620.945 45 8

04.620.950 50 8

04.620.955 55 4

04.620.960 60 4

04.620.965 65 4

04.620.970 70 4

04.620.975 75 4

04.620.980 80 4

04.620.990 90 4

04.620.999 100 4

Titanium Pangea Auxiliary Polyaxial Screw Set(01.620.024)690.232 Graphic Case, for Titanium Pangea Auxiliary

Polyaxial Screws

Titanium Pangea Polyaxial Pedicle Screws, dual core, withStarDrive T25 recess

*Ti-6Al-7Nb alloy

04.620.000 Titanium Pangea Locking Cap, 20 ea.

Page 53: PangeaSystem. For deformity correction.synthes.vo.llnwd.net/o16/Mobile/Synthes North America/Product Sup… · Low Profile. Indications The Pangea Deformity Correction System consists

Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380Telephone: (610) 719-5000To order: (800) 523-0322Fax: (610) 251-9056

Synthes (Canada) Ltd.2566 Meadowpine BoulevardMississauga, Ontario L5N 6P9Telephone: (905) 567-0440To order: (800) 668-1119Fax: (905) 567-3185

© 2007 Synthes, Inc. or its affiliates. All rights reserved. CerviFix, Pangea, and Synthes are trademarks of Synthes, Inc. or its affiliates. Printed in U.S.A. 4/07 J6718-A

www.synthes.com


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