Pangea System Technique Guide

Pangea System. For deformity
correction.
Technique Guide
Instruments and implants
approved by the AO Foundation
Table of Contents
Introduction
Surgical Technique
Product Information
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-threading
and ensures construct rigidity.
Versatile
Instruments optimize correction of
complex deformities.
2
Synthes Spine Pangea System
Strong
6.0 mm rods provide long-term
stability and maintain deformity
correction.
Low Profile
Screws and hooks minimize anatomical
interference.
Synthes Spine
3
Indications
The Pangea Deformity Correction System consists of noncervical spinal fixation devices intended for use as a posterior
pedicle screw fixation system (T1–S2), a posterior hook fixation
system (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/or
lordosis, 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 the
posterior pedicle screw construct.
When used with 3.5 mm/6.0 mm parallel connectors, the
Pangea Deformity Correction System can be linked to the
Synthes CerviFix System. In addition, when used with
5.0 mm/6.0 mm parallel connectors, the Pangea Deformity
Correction System can be linked to the Synthes Small Stature
USS System. In addition, the Pangea Deformity Correction
System can be interchanged with all USS 6.0 mm rods and
transconnectors.
Please refer to product insert (GP0001) for complete system
description, warnings and precautions.
4
Synthes Spine Pangea System
Screw Insertion
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. Use
the appropriate probe to open the pedicle canal. For selecting
the appropriate length screw, the markings on the probe
indicate the pedicle depth.
All Pangea screws are self-tapping; however, if tapping is
preferred, use the appropriate tap and tap handle.
2a
Insert Pangea monoaxial screw
Instrument
03.622.004
Pangea Footed Screwdriver with Straight
Handle
Insert the self-retaining Pangea Footed Screwdriver into the
head of the appropriate monoaxial screw.
Insert the monoaxial screw into the prepared pedicle.
Repeat for each screw.
Synthes Spine
5
Screw Insertion continued
2a
Insert Pangea monoaxial screw continued
Option: Pangea Footed Screwdriver and Holding Sleeve
Inner sleeve
Outer sleeve
Instruments
03.622.003
Pangea Holding Sleeve
03.622.004
Pangea Footed Screwdriver with Straight
Handle
Assemble Holding Sleeve
Place the Pangea Footed Screwdriver through the outer
sleeve and pull sleeve back until it contacts the screwdriver
handle (Figure 1).
Place the inner sleeve over the screwdriver and under the
outer sleeve (Figure 2). Use the window on the outer sleeve
to visualize the keyway that will secure the inner sleeve to
the screwdriver. The inner sleeve’s keyway should be inserted
into the protruding pin on the screwdriver shaft. Turn the
inner sleeve into the slot to secure (Figure 3).
Insert screw into screwdriver
After ensuring that the outer sleeve is fully retracted, insert
the screwdriver tip into the head of the appropriate monoaxial screw. Push the outer sleeve down until it stops (Figure 4).
Insert the monoaxial screw into the prepared pedicle.
Figure 1
Figure 2
Figure 3
Figure 4
Remove screwdriver from implant
After the screw is inserted, pull the outer sleeve back to
disengage the screwdriver from the screw.
6
Synthes Spine Pangea System
Alternative screwdrivers for monoaxial screw insertion
with 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 Footed
Screwdriver Shaft, short
2b
Insert Pangea polyaxial screw
Instruments
03.620.001
StarDrive Screwdriver, T25, with T-Handle
03.620.003
StarDrive Screwdriver Shaft, T25, 6 mm hex
coupling
03.620.005
Ratchet T-Handle with low toggle
03.620.006
StarDrive Screwdriver, T25, with straight
handle
Use the StarDrive Screwdriver to select a polyaxial screw from
the screw rack. Place the self-retaining screwdriver tip firmly
into the star recess and pick up the screw.
Insert the screw into the prepared pedicle.
Repeat for each screw.
*Also available
Synthes Spine
7
Screw Insertion continued
2b
Insert 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, the
Pangea Stabilization Sleeve may be used to stabilize the
screw 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 the
screw in the screw rack and slide the stabilization sleeve
down into the screw head.
The sleeve should be held during screw insertion to prevent
the head from turning as the screw advances.
8
Synthes Spine Pangea System
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 coupling
to keep the screw secure.
Tensioning
knob
Assembly
button
Figure 1
To assemble, press and hold down the assembly button while
sliding the sleeve toward the handle until it stops (Figure 1).
Then push the outer knurled sleeve toward the handle (Figure
2). Ensure that the tensioning knob is loosened (Figure 3).
Place the screwdriver tip firmly into the StarDrive recess of
the screw in the screw rack, and turn the retaining sleeve
to align the tips with the rod slot.
Figure 2
Push the outer sleeve down to capture and pick up the screw.
After the screw is loaded, the tensioning knob may be tightened to apply more retaining force on the screw (Figure 4).
Figure 3
Figure 4
Synthes Spine
9
Screw Insertion continued
2b
Insert Pangea polyaxial screw continued
Alternative 2: Pangea Retaining Sleeve continued
Insert the Pangea screw into the prepared pedicle. The outer
sleeve may be held during screw insertion.
Note: Do not press the assembly button during screw
insertion. If the assembly button is accidentally pressed while
the screw is loaded, the red indicator line will be visible on
the sleeve. If this happens, pull up the outer sleeve and push
it back down to reload the screw.
To release the sleeve, pull up on the outer sleeve and remove
the screwdriver. Repeat for each screw.
3
Confirm implant position
Position of the implants should be confirmed radiographically.
10
Synthes Spine Pangea System
Hook Placement
4a
Prepare 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.
4b
Prepare pedicle for a pedicle hook
Instrument
03.622.012
Pedicle Finder
Using the Pedicle Finder, open the facet capsule and locate
the pedicle.
Remove a small piece of the inferior articular process to
ensure proper seating of the pedicle hook. Pedicle hooks
should be placed in an up-going direction only.
Synthes Spine
11
Hook Placement continued
4c
Prepare transverse process for transverse process hook
Instrument
03.622.030
Transverse Process Finder
Use the Transverse Process Finder to separate the ligamentum flavum from the undersurface of the transverse process.
5
Place 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 Holding
Forceps. Place the hook in the desired location. The Hook
Positioner may also be used to facilitate placement of the
hook.
6
Place remaining hooks
Repeat steps 4 and 5 to place hooks as determined in the
preoperative plan.
12
Synthes Spine Pangea System
Rod Contouring
7
Determine 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 Coated
Rod Template. Cut the rod to length, as needed.
8
Contour the rod
Instruments
03.620.020
Rod Bender with radius adjustment and
spring opening
03.622.060* Pipe Benders, with long handles
388.112
388.113
In Situ Bender, right and left
Contour the rod to match the rod template using the Rod
Bender. Alternatively, the In Situ Benders or Pipe Benders
may be used to contour the rod.
*Also available
Synthes Spine
13
Rod Reduction and Construct Assembly
9
Align 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 into
the openings of the top-loading screws or hooks. If necessary, 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.
14
Synthes Spine Pangea System
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 the
implant opening.
Option 3: Vertical Reducer
Instrument
03.622.095
Pangea Vertical Reducer
Before placing the Pangea Vertical Reducer over the implant
head, ensure that the ratchet handle is fully open. Place the
vertical reducer over the implant head and squeeze the handle
to seat the rod.
Note: The knob should be loosened and the tube retracted
for cleaning and sterilization.
Synthes Spine
15
Rod Reduction and Construct Assembly continued
Bi-Planar Persuader
9
Implant Holder
Align rod to hooks and screws continued
Ratcheting
handle
Option 4: Bi-Planar Persuader
Instruments
03.622.090
Bi-Planar Persuader
03.622.091
Implant Holder, for
Bi-Planar Persuader
Assembled
Implant Holder
Use the Bi-Planar Persuader and Implant
Holder in situations where the rod is
lateral to and/or above the implant
opening.
Directional
switch
Note: The sleeve and Implant Holder
should be disassembled prior to cleaning
and sterilization.
Directional
knob
Assemble Implant Holder
Slide the sleeve onto the Implant Holder
so that the ball detents on the sleeve
snap into the groove on the Implant
Holder. This is the “UP” position of the
sleeve on the Implant Holder.
Attach Implant
Attach the Implant Holder to the side of
the screw or hook by snapping it onto
the mating features on the side of the
implant. Use a rolling action to first snap
on one side of the implant and then the
other side. Slide the sleeve down until
it stops.
16
Synthes Spine Pangea System
Approximating
arms
Sleeve for
Implant Holder
Engage Rod
Place the Bi-Planar Persuader over the
Implant Holder. Ensure that the directional switch is in the “DOWN” position.
Turn the silver directional knob to move
the Persuader along the Implant
Holder.
Down
To move the Persuader downward, flip
the directional switch to the “D” or
“DOWN” position. Rotate the directional knob counterclockwise.
Up
To move the Persuader upward, flip the
directional switch to the “U” or “UP”
position. Rotate the directional knob
clockwise.
Synthes Spine
17
Rod Reduction and Construct Assembly continued
9
Align rod to hooks and screws continued
Option 4: Bi-Planar Persuader continued
Engage the rod with the approximating arms and squeeze
the ratcheting handle to position the rod above the implant
opening. Rotate the directional knob to fully seat the rod
within the implant opening.
The approximating arms can also be used to pull the rod up
and over the side of the implant.
When using the Bi-Planar Persuader to reduce the rod, the
approximating arms will serve as a guide for the locking cap
screwdriver.
10
Insert 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 Locking Cap and remove the cap from the graphic case. Align the
black etching on the locking cap with the rod.
When the cap is in the correct position, it will drop slightly
into the Pangea implant head. Push down on the cap to
snap it into the Pangea head. Turn the locking cap a quarter
turn until the cap stops. The cap will snap into this position.
When the locking cap is fully engaged, the black etching will
be perpendicular to the rod.
18
Synthes Spine Pangea System
Position of etch mark
on locking cap
If provisional tightening is desired, turn the screwdriver further
to 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 arms
disengage from the rod. Slide the sleeve up the Implant
Holder and release the persuader from the implant.
Synthes Spine
19
Rod Reduction and Construct Assembly continued
10
Insert 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 StarDrive
Screwdriver to the top groove. Thread the Pangea Locking
Cap Driver clockwise onto the top of the setscrew until it is
snug. Turn the Pangea Locking Cap Driver clockwise to
rotate the cap one quarter turn.
20
Synthes Spine Pangea System
Important: Unthread the Pangea Locking Cap Driver
counterclockwise (while holding onto screwdriver handle)
and retract it before driving the setscrew further with the
StarDrive Screwdriver.
Notes:
It is possible to visually identify locking caps that have had
their initial preload disturbed by examining the alignment of
the setscrew to the cap.
If the etch marks are not aligned, the setscrew is not ready to
carry the cap through the quarter turn. The locking cap driver
option should be used in this situation.
Set
Not set
11
Remove rod reduction instrument
Remove the rod reduction instrument after the locking cap
is inserted.
Synthes Spine
21
Deformity Correction
Deformity correction can be assisted by additional manipulation of the construct.
In Situ bending
Instruments
03.622.062
03.622.061
Coronal Rod Benders, right and left
388.112
388.113
In Situ Benders, right and left
Use the In Situ Benders, right and left, to contour the rod in
the sagittal plane and the Coronal Rod Benders, right and
left, to contour the rod in the coronal plane.
Rod rotation
If 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 rotate it in the proper direction. Use the StarDrive Screwdriver to
tighten the setscrews after achieving the desired rod rotation.
22
Synthes Spine Pangea System
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 Rotation
Wrench can be applied to the end of the rod containing the
hex and rotated. Use the StarDrive Screwdriver to tighten the
setscrews after achieving the desired rod rotation.
Derotation
Instrument
03.622.007
Pangea Derotation Instrument
If a derotation maneuver is desired, ensure that the locking
cap setscrews are not tightened.
Place a Pangea Derotation Instrument (tube) over each
selected screw. Use the tubes as leverage to maneuver the
vertebral bodies. Insert the StarDrive Screwdriver through
the tubes to tighten the setscrews.
Synthes Spine
23
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 against
which to distract.
Use the Parallel Distractor for 6.0 mm rods to distract the
construct. Once in the desired position, tighten the setscrews
of the locking caps with the StarDrive Screwdriver.
24
Synthes Spine Pangea System
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 against
which to compress.
Use the Parallel Compressor for 6.0 mm rods to compress
the construct. Once in the desired position, tighten the
setscrews of the locking caps with the StarDrive Screwdriver.
*Also available
Synthes Spine
25
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 Torque
Limiting Handle and insert the shaft through the Countertorque and into the locking cap setscrew. Tighten until the
Torque Limiting Handle clicks, which indicates that 10 Nm of
torque has been applied.
Repeat for all locking caps.
26
Synthes Spine Pangea System
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 construct and to increase rotational stability.
Use the Transconnector Template to measure the distance
between the two rods.
Choose a transconnector of the appropriate length. Ensure
that the transconnector setscrews are not advanced. Apply
the transconnector to the rods. Use the 2.5 mm Hexagonal
Screwdriver to secure the transconnector to the rods by
tightening the setscrews on each end.
For a transconnector with angular adjustment, tighten the
stargrind setscrew to lock the angle between the rods.
To adjust the length of the transconnector, slide the ends to
the appropriate length and tighten the center setscrew.
Note: If any part of the construct requires further adjustment, all transconnector setscrews must be loosened. After
final adjustment, retighten all the setscrews.
Synthes Spine
27
Optional Surgical Technique—Transverse Bar Attachment
The transverse bar provides an extension to the hook or
monoaxial 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 the
setscrew with the 2.5 mm Hexagonal Screwdriver.
Introduce the transverse bar into the screw or transverse
hook opening. Use the Rod Pusher if necessary.
Secure the transverse bar to the hook or screw by inserting
the locking cap and tightening the setscrew.
Secure the transverse bar to the rod by tightening the
setscrew firmly.
28
Synthes Spine Pangea System
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
Reduction feature
for lateral
attachment
1.3 mm space
to accommodate
bent rod
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 locking
cap installation
– Screw head contains features that mate with rod
reduction instruments
Synthes Spine
29
Implants continued
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 the
screw or transverse hook
– Lengths of 15 mm, 20 mm, 25 mm and 30 mm
– Eliminate the need for severe rod contours which might
otherwise be required for direct hook- or screw-to-rod
connection
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 intraoperative rod bending*
*Also available
30
Synthes Spine Pangea System
Pangea Hooks
Implant
Placement
Pedicle Hook
Articular Process
Lamina Hook
Sizes
Blade direction
(Up–Down)
Description
Up
Bifid blade tip grips the pedicle for secure hook placement
S
M
Lamina
XS
S
M
L
Up Down
Multiple hook sizes fit varied
patient anatomies
Tall Body Lamina Hook
Lamina
XS
S
M
L
Up Down
Increased body height eases
rod reduction in the dorsoventral 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
Synthes Spine
31
Implants continued
Pangea Hooks continued
Implant
Placement
Thoracic Lamina Hook
Lamina
Offset Lamina
Hook
Transverse Process
Hook
32
Blade direction
(Up–Down)
Description
M
Up Down
Small hook blade is optimal in
thoracic spine
Lamina
M
Up Down
Eases rod reduction when rod
is not aligned with the hook.
Offset lamina hooks are also
available with up- or downangled hook blades.
Transverse Process
M
Up Down
Left and right transverse
process hooks offer angles
suited for ideal fit on
transverse processes
Synthes Spine Pangea System
Sizes
Instruments
For Deformity Preparation
388.656
Awl with Palm Handle
4 mm tip diameter
03.622.005
Thoracic Pedicle Probe
3.0 mm width at tip
388.536
Pedicle Probe with Palm Handle, for 4.0 mm
and 4.2 mm screws
3.0 mm width at tip
388.655
Probe with Palm Handle
3.7 mm width at tip
388.657
Curved Probe with Palm Handle
3.7 mm width at tip
388.545
Straight Ball Tip Probe
388.546
Curved Ball Tip Probe
Synthes Spine
33
Instruments continued
For Deformity Preparation continued
03.620.005
Ratchet T-Handle with low toggle
03.620.104
03.620.105
03.620.106
03.620.107
03.620.108
03.620.109
Taps, 6 mm hex coupling
For 4.0 mm Dual Core Screws
For 5.0 mm Dual Core Screws
For 6.0 mm Dual Core Screws
For 7.0 mm Dual Core Screws
For 8.0 mm Dual Core Screws
For 9.0 mm Dual Core Screws
For Monoaxial Screws
03.622.004
Pangea Footed Screwdriver with Straight
Handle
03.622.015* Pangea Footed Screwdriver with T-Handle
03.622.002
Pangea Footed Screwdriver Shaft,
6 mm hex coupling
03.622.003
Pangea Holding Sleeve, for footed
screwdrivers
03.622.008
Pangea Monoaxial Screw Alignment Tool
*Also available
34
Synthes Spine Pangea System
For Polyaxial Screws and Locking Caps
03.620.006
StarDrive Screwdriver, T25, with straight
handle
03.620.001
StarDrive Screwdriver, T25, with T-handle
03.620.003
StarDrive Screwdriver Shaft, T25,
6 mm hex coupling
03.620.013
Pangea Locking Cap Driver with T-Handle
03.622.016* Pangea Locking Cap Driver with Knurled
Handle
03.620.005
Ratchet T-Handle with low toggle,
6 mm hex coupling
03.620.100
Ratchet Straight Handle with low toggle,
6 mm hex coupling
*Also available
Synthes Spine
35
Instruments continued
For Polyaxial Screws and Locking Caps continued
03.620.004
Pangea Stabilization Sleeve
03.620.023
Pangea Retaining Sleeve
03.620.014
Pangea Remobilization Tool
For Hook Preparation
03.622.012
Pedicle Finder
03.622.020
388.104
388.105
388.106
Lamina Finders
Extra small
Small
Medium
Large
03.622.030
Transverse Process Finder
36
Synthes Spine Pangea System
03.622.020
For Hook Placement
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
For Rod Contouring
03.620.020
Rod Bender with radius adjustment and
spring opening
03.622.060* Pipe Benders, with long handles
388.902
388.905
Coated Rod Templates, for 6.0 mm rods
150 mm
500 mm
*Also available
Synthes Spine
37
Instruments continued
For Construct Assembly
03.622.081
Rod Holding Forceps with Clamp Grip
328.028
Rod Holding Forceps, straight
For Rod Reduction
03.622.095
Pangea Vertical Reducer
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
38
Synthes Spine Pangea System
03.622.090
Bi-Planar Persuader, for Pangea
03.622.091
Implant Holder, for Bi-Planar Persuader
388.114
Rod Pusher
03.620.011
Pangea Rod Pusher, countertorque
For Deformity Correction
03.622.061
03.622.062
Coronal Rod Bender, left, for 6.0 mm rods
Coronal Rod Bender, right, for 6.0 mm rods
388.112
388.113
In Situ Bender, right
In Situ Bender, left
Synthes Spine
39
Instruments continued
For Deformity Correction continued
03.622.081
Rod Holding Forceps with Clamp Grip
03.622.084
Rod Rotation Wrench, angled, for 6.0 mm
hex-end rods
03.622.007
Pangea Derotation Instrument
For Distraction and Compression
03.622.006* Parallel Compressor with Extended Travel
03.622.070
Parallel Compressor, for 6.0 mm rods
03.622.071
Parallel Distractor, for 6.0 mm rods
*Also available
40
Synthes Spine Pangea System
03.622.081
Rod Holding Forceps with Clamp Grip
For Final Tightening
03.620.022
StarDrive Screwdriver Shaft, T25, 6 mm hex
coupling, short
03.620.019
10 Nm Torque Limiting Handle, 6 mm
hex coupling
03.622.018
Countertorque, for StarDrive Screwdrivers, T25
For Transconnector
03.620.021
Transconnector Template
388.395
2.5 mm Hexagonal Screwdriver, long
Synthes Spine
41
Pangea Deformity Instrument and Titanium Monoaxial Screw Set
(01.622.420)
Graphic Case
60.622.420 Graphic Case for Pangea Titanium Monoaxial
Screws and Instruments
Implants
4.0 mm Titanium Pangea
Monoaxial Pedicle Screws
Thread
Length
(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 Pangea
Monoaxial Pedicle Screws
Thread
Length
(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 Pangea
Monoaxial Pedicle Screws
04.622.625
25
04.622.630
30
04.622.635
35
04.622.640
40
04.622.645
45
04.622.650
50
04.622.655
55
04.622.660
60
04.622.665
65
2
4
6
8
8
6
4
4
4
7.0 mm Titanium Pangea
Monoaxial Pedicle Screws
04.622.725
25
04.622.730
30
04.622.735
35
04.622.740
40
04.622.745
45
04.622.750
50
04.622.755
55
04.622.760
60
04.622.765
65
8.0 mm Titanium Pangea
Monoaxial Pedicle Screws
04.622.825
25
04.622.830
30
04.622.835
35
04.622.840
40
04.622.845
45
04.622.850
50
04.622.855
55
04.622.860
60
04.622.865
65
2
2
2
2
2
2
2
2
2
42
Synthes Spine Pangea System
2
4
6
8
8
4
2
2
2
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 refer
to graphic case package insert.
Method
Cycle
Temperature
Exposure Time
Steam
Prevacuum
(Wrapped)
132°–135°C
(270°–275°F)
10 Minutes
(20 Minute Dry time)
Steam
Gravity Displacement
(Wrapped)
132°–135°C
(270°–275°F)
28 Minutes
(20 Minute Dry time)
Implants continued
04.620.000 Titanium Pangea Locking Cap, 40 ea.
6.0 mm Titanium Transverse Bars, 2 ea.
Length (mm)
499.450
15
499.452
499.451
20
499.453
Length (mm)
25
30
Instruments
03.622.003 Pangea Holding Sleeve, for Footed Screwdrivers, 2 ea.
03.622.004 Pangea Footed Screwdriver with Straight
Handle, 2 ea.
03.622.008 Pangea Monoaxial Screw Alignment Tool
Synthes Spine
43
Pangea Hook Instrument and Titanium Implant Set (01.622.410)
Graphic Case
60.622.410 Graphic Case for Pangea Titanium Hooks and
Instruments
Titanium Implants
04.622.010
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
44
Synthes Spine Pangea System
Instruments
03.622.012
03.622.020
388.104
388.105
388.106
03.622.030
03.622.040
03.622.041
03.622.042
388.110
Pedicle Finder
Extra Small Lamina Finder
Small Lamina Finder
Medium Lamina Finder
Large Lamina Finder
Transverse Process Finder
Hook Holding Forceps, lateral
Hook Holding Forceps, straight, 2 ea.
Hook Holding Forceps, curved
Hook Positioner
Titanium Pangea Deformity Rod and Transconnector Implant Set (01.622.430)
Graphic Case
60.622.430 Graphic Case, for Titanium Pangea Deformity
Rod and Transconnector Implants
Implants
6.0 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
Instrument
03.620.021
Measuring Template for Transconnectors
Synthes Spine
45
Pangea Basic Instrument Set (01.622.300)
Graphic Case
690.243
Graphic Case, for Pangea Basic Instruments
Instruments
03.620.001
03.620.003
03.620.004
03.620.005
03.620.006
03.620.009
03.620.010
03.620.011
03.620.013
03.620.019
03.620.022
03.620.023
328.028
388.114
388.395
46
StarDrive Screwdriver, T25, with T-Handle
StarDrive Screwdriver Shaft, T25, 6 mm hex
coupling, 2 ea.
Pangea Stabilization Sleeve, 2 ea.
Ratchet T-Handle with low toggle, 6 mm
hex coupling, 2 ea.
StarDrive Screwdriver, T25, with straight
handle, 2 ea.
Pangea Small Rocker Fork, with straight shaft
Pangea Small Rocker Fork, with curved shaft
Pangea Rod Pusher, countertorque, 2 ea.
Pangea Locking Cap Driver with T-Handle,
2 ea.
10 Nm Torque Limiting Handle, 6 mm hex
coupling
StarDrive Screwdriver Shaft, T25, 6 mm hex
coupling, short, 2 ea.
Pangea Retaining Sleeve, 2 ea.
Rod Holding Forceps, straight
Rod Pusher
2.5 mm Hexagonal Screwdriver, long
Synthes Spine Pangea System
Pangea Deformity Preparation Instrument Set (01.622.310)
Graphic Case
60.622.310
Graphic Case, for Pangea Deformity
Preparation Instruments
Instruments
Taps, 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
388.536
388.545
388.546
388.655
388.656
388.657
Thoracic Pedicle Probe
Pedicle Probe with Palm Handle, for 4.0 mm/
4.2 mm Screws
Straight Ball Tip Probe
Curved Ball Tip Probe
Probe with Palm Handle
Awl with Palm Handle
Curved Probe with Palm Handle
Synthes Spine
47
Pangea Deformity Rod Instrument Set (01.622.320)
Graphic Case
60.622.320
Graphic Case, for Pangea Deformity Rod
Instruments
Instruments
03.620.020
03.622.061
03.622.062
03.622.070
03.622.071
03.622.081
03.622.084
03.622.095
388.112
388.113
Rod Bender with radius adjustment
Coronal Rod Bender, left, for 6.0 mm rods
Coronal Rod Bender, right, for 6.0 mm rods
Parallel Compressor, for 6.0 mm rods
Parallel Distractor, for 6.0 mm rods
Rod Holding Forceps with Clamp Grip, 2 ea.
Rod Rotation Wrench, angled, for 6.0 mm
hex-end rods
Pangea Vertical Reducer
In Situ Bender, right
In Situ Bender, left
388.902
388.905
Coated Rod Templates, for 6.0 mm Rods
150 mm
500 mm
48
Synthes Spine Pangea Deformity Correction System
Pangea Deformity Correction Instrument Set (01.622.330)
Graphic Case
60.622.330
Graphic Case for Deformity Correction
Instruments
Instruments
03.620.014
03.622.002
03.622.007
03.622.018
03.622.055
03.622.090
03.622.091
Pangea Remobilization Tool
Pangea Footed Screwdriver Shaft, 6 mm hex
coupling, 2 ea.
Pangea Derotation Instrument, 4 ea.
Countertorque, for StarDrive Screwdrivers, T25
Pangea Medium Rocker Fork, with curved
shaft
Bi-Planar Persuader, for Pangea, 2 ea.
Implant Holder, for Bi-Planar Persuader, 2 ea.
Synthes Spine
49
Also Available
Titanium Pangea Deformity Auxiliary Monoaxial Screw
Set (01.622.440)
60.622.440 Graphic Case for Titanium Pangea Monoaxial
Auxiliary Screws
Titanium Pangea Polyaxial Screw Implant Set
(01.622.450)
690.234
Graphic Case, for Titanium Pangea Polyaxial
Screws
Titanium Pangea Monoaxial Pedicle Screws, dual core
Titanium Pangea Polyaxial Pedicle Screws, dual core, with
StarDrive T25 recess
7.0 mm dia.
04.622.770
04.622.775
04.622.780
04.622.790
04.622.799
Thread
Length
(mm)
70
75
80
90
100
8.0 mm dia.
04.622.870
04.622.875
04.622.880
04.622.890
04.622.899
70
75
80
90
100
9.0 mm dia.
04.622.930
04.622.935
04.622.940
04.622.945
04.622.950
04.622.955
04.622.960
04.622.965
04.622.970
04.622.975
04.622.980
04.622.990
04.622.999
50
30
35
40
45
50
55
60
65
70
75
80
90
100
Qty.
4
4
4
4
4
4
4
4
4
4
2
2
2
2
2
2
2
2
2
2
2
2
2
Synthes Spine Pangea System
4.0 mm dia.
04.620.420
04.620.425
04.620.428
04.620.430
04.620.432
04.620.435
04.620.438
04.620.440
04.620.445
Thread
Length
(mm)
20
25
28
30
32
35
38
40
45
5.0 mm dia.
04.620.530
04.620.535
04.620.540
04.620.545
04.620.550
30
35
40
45
50
6
6
6
6
4
6.0 mm dia.
04.620.630
04.620.635
04.620.640
04.620.645
04.620.650
04.620.655
30
35
40
45
50
55
4
8
12
12
8
4
Qty.
4
8
4
8
4
8
4
4
4
7.0 mm dia.
04.620.730
04.620.735
04.620.740
04.620.745
04.620.750
04.620.755
Thread
Length
(mm)
30
35
40
45
50
55
8.0 mm dia.
04.620.830
04.620.835
04.620.840
04.620.845
04.620.850
04.620.855
30
35
40
45
50
55
Qty.
4
4
8
8
6
4
2
4
4
4
4
2
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, with
StarDrive T25 recess
6.0 mm dia.
04.620.665
Thread
Length
(mm)
65
Qty.
4
9.0 mm dia.
04.620.930
04.620.935
04.620.940
04.620.945
04.620.950
04.620.955
04.620.960
04.620.965
04.620.970
04.620.975
04.620.980
04.620.990
04.620.999
Thread
Length
(mm)
30
35
40
45
50
55
60
65
70
75
80
90
100
7.0 mm dia.
04.620.765
04.620.770
04.620.775
04.620.780
04.620.790
04.620.799
65
70
75
80
90
100
4
4
4
4
4
4
8.0 mm dia.
04.620.865
04.620.870
04.620.875
04.620.880
04.620.890
04.620.899
65
70
75
80
90
100
2
4
4
4
4
4
04.620.000
Titanium Pangea Locking Cap, 20 ea.
Qty.
4
4
8
8
8
4
4
4
4
4
4
4
4
Implants
6.0 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
Instruments
03.620.015
03.620.026
03.620.100
03.622.006
03.622.015
03.622.016
03.622.032
03.622.033
03.622.060
03.622.096
Polyaxial Head Positioner
Pangea Cap Introducer
Ratchet Straight Handle with low toggle,
6 mm hex coupling
Parallel Compressor with Extended Travel
Pangea Footed Screwdriver with T-Handle
Pangea Locking Cap Driver with Knurled
Handle
Pangea Footed Screwdriver Shaft, short
Holding Sleeve for Pangea Footed
Screwdriver Shaft, short
Pipe Benders, with long handles (2/pkg.)
Pangea Vertical Reducer, long
Modules and Screw Racks
60.622.411
Module for Titanium Pangea Hooks
60.622.412
Module for Titanium Pangea Specialty Hooks
60.622.421
Screw Rack, for Titanium Pangea Monoaxial
Screws
60.622.422
Module, for Titanium Transverse Bars
60.622.431
Module, for Titanium Transconnectors
690.241
Module, for Pangea Locking Caps
*Ti-6Al-7Nb alloy
Synthes Spine
51
Synthes Spine
1302 Wrights Lane East
West Chester, PA 19380
Telephone: (610) 719-5000
To order: (800) 523-0322
Fax: (610) 251-9056
© 2007 Synthes, Inc. or its affiliates. All rights reserved.
Synthes (Canada) Ltd.
2566 Meadowpine Boulevard
Mississauga, Ontario L5N 6P9
Telephone: (905) 567-0440
To order: (800) 668-1119
Fax: (905) 567-3185
CerviFix, Pangea, and Synthes are trademarks of Synthes, Inc. or its affiliates.
www.synthes.com
Printed in U.S.A. 4/07 J6718-A