PangeaSystem. For deformity correction.synthes.vo.llnwd.net/o16/Mobile/Synthes North America/Product...
Transcript of PangeaSystem. For deformity correction.synthes.vo.llnwd.net/o16/Mobile/Synthes North America/Product...
Instruments and implants approved by the AO Foundation
Pangea System. For deformitycorrection.
Technique Guide
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
Pangea System
Simple
Locking cap eliminates cross-threadingand ensures construct rigidity.
Instruments optimize correction ofcomplex deformities.
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Versatile
Strong
6.0 mm rods provide long-term stability and maintain deformity correction.
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Screws and hooks minimize anatomicalinterference.
Low Profile
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.
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Screw Insertion
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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.
Figure 1 Figure 2
Figure 3 Figure 4
Screw Insertion continued
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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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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
Screw Insertion continued
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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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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
Screw Insertion continued
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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
Hook Placement
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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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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
Rod Contouring
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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
Rod Reduction and Construct Assembly
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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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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.
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.
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Bi-Planar Persuader
Ratchetinghandle
Directionalswitch
Directionalknob
Approximatingarms
Implant Holder
Sleeve for Implant Holder
Assembled Implant Holder
continued
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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.
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.
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Position of etch markon locking cap
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.
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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.
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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.
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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.
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.
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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.
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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.
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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.
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*Also available
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.
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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.
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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.
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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
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Reduction featurefor lateral attachment
1.3 mm space to accommodatebent rod
Implants continued
*Also available
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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*
Pangea Hooks
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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
Implants continued
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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
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
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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
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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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
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
03.620.020 Rod Bender with radius adjustment andspring opening
03.622.060* Pipe Benders, with long handles
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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
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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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
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
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
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
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
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
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
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
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
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
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.
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
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.
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
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