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Craniomaxillofacial (CMF) DistractionSystem. A modular family of internaldistraction devices to lengthen the mandi-bular body and ramus.
Technique Guide
Introduction
Surgical Technique
Product Information
Bibliography
Craniomaxillofacial (CMF) Distraction System 2
Indications 4
Preoperative Planning 5
Distractor Assembly 6
Mandible Body Lengthening 17
Postoperative Management 25
Extension Arm Removal 28
Device Removal 30
Implants 31
Screws 36
Instruments 38
Set 44
45
Table of Contents
Synthes 1
+ + =
1.0 mm 1.3 mm
1.5 mm 2.0 mm
1.0 mm 1.3 mm
1.5 mm 2.0 mm
2 Synthes Craniomaxillofacial (CMF) Distraction System Technique Guide
Craniomaxillofacial (CMF) DistractionSystem. A modular family of internaldistraction devices to lengthen themandibular body and ramus.
A modular system of intraoral distraction devices offered in avariety of designs and sizes to fit patient anatomy.
Footplates– Available in cloverleaf and mesh designs– Available in four sizes for use in a wide range of patients:
1.0 mm and 1.3 mm for children under 12 months of age,and 1.5 mm and 2.0 mm for older patients
– 2.0 mm footplates with threaded screw holes accept Syn-thes 2.0 mm titanium locking screws for greater stability
Cloverleaf footplates
2.0 mm titanium locking screw
Mesh footplates
Synthes 3
Rigid extension arm
Flexible extension arm
End-translating (BC distractor shown with universal joint)
Center-translating (AB distractor shown without universal joint)
Distractor bodies– Offered in center-translating (AB distractor) and endtrans-
lating (BC distractor) designs, for maximum placement op-tions of the distractor on the mandible
– Available with or without a universal joint. Universal jointsallow ±35º of angulation of extension arms
AB distractor bodies – Footplates can be placed more anteriorly on the mandible
with half of the distractor initially positioned posterior tothe osteotomy
BC distractor bodies– Footplates can be placed more posteriorly on the mandible
with the distractor body initially positioned either anterioror posterior to the osteotomy, depending on the orienta-tion
Extension arms – Allow the point of activation to be moved away from the
distractor body for easier access with the activation instru-ment
– May be placed intraorally or percutaneously– May be removed for patient comfort, during the consolida-
tion phase, without a surgical procedure
4 Synthes Craniomaxillofacial (CMF) Distraction System Technique Guide
The Synthes Craniofacial (CMF) Distraction System is in-tended for use as a bone stabilizer and lengthening (and/ortransport) device for correction of congenital deficiencies orpost-traumatic defects of the mandibular body and ramuswhere gradual bone distraction is required. The system of 1.0 mm and 1.3 mm is recommended for children under theage of 12 months and 1.5 mm and 2.0 mm is recommendedfor older patients.
Indications
Synthes 5
Preoperative Planning
Determine the postdistraction anatomic goal by conductingan evaluation of the craniofacial pathology and asymmetrythrough clinical exam, CT scan, cephalogram and/orpanoramic x-ray. Anatomical models are beneficial for select-ing appropriate distractor components, determining the loca-tion of the osteotomy and placement of the devices, and forpre-bending the footplates.
6 Synthes Craniomaxillofacial (CMF) Distraction System Technique Guide
Distractor Assembly
A-stylefootplate
B-stylefootplate
C-stylefootplate
2Select footplates
Select two footplates according to the treatment plan andchosen distractor design, giving special consideration to thepatient’s anatomy.
Note: Footplates must mate with the selected distractorbody. If an AB distractor body is selected, one A-style andone B-style footplate must be used. If a BC distractor body isselected, one B-style and one C-style footplate must be used.
1Select distractor body
Select the appropriate design and length distractor body ac-cording to the treatment plan.
Note: To ensure that the soft tissue does not obstruct the ac-tivation hex during distraction, the next longer size distractorbody and/or extension arm may need to be used.
BC distractor body (end translating) shownwith universal joint and 1.5 mm mesh footplates
AB distractor body (center translating) shown with 1.5 mm mesh footplates
Synthes 7
There are different steps for attaching the footplates to theAB and BC distractor bodies.
3aAssemble footplates-AB distractor
Instruments
311.005 Screwdriver Handle with hex coupling,small
311.006 Screwdriver Handle with hex coupling,medium
313.252 1.5 mm/2.0 mm Screwdriver Blade,self-retaining, PlusDrive, 96 mm
313.253 1.5 mm/2.0 mm Screwdriver Blade,self-retaining, PlusDrive, 76 mm
Use the 1.5 mm/2.0 mm screwdriver blade to remove themachine screw and collar from the distractor body.
Set these aside for later reassembly.
Remove the lead screw by sliding it out of the distractorbody.
collar
8 Synthes Craniomaxillofacial (CMF) Distraction System Technique Guide
Thread the B-style footplate onto the hex end of the leadscrew and rotate the footplate counterclockwise until itreaches the center of the lead screw. An etched “B” alongwith an arrow on the center of the lead screw indicatesproper placement of the B-style footplate.
Distractor Assembly
hex end
non-hex end
Thread the A-style footplate onto the opposite end of thelead screw and rotate the footplate clockwise until it reachesthe center of the lead screw. An “A” and an arrow areetched on the center of the lead screw to assist in assem-bling the footplate.
– Align the footplates parallel to each other at the center ofthe lead screw.
– Position the footplates so that the screw holes point awayfrom one another, as shown.
Correct
Incorrect
hex end
Synthes 9
Insert the hex end of the lead screw (the end with the B-stylefootplate) back into the distractor body.
Slide the lead screw all the way into the distractor until itseats in the activation hex.
Retrieve the previously disassembled machine screw and collar.
Place the collar onto the distractor body. Etched lines on thecollar and distractor body aid in realignment.
Correct Incorrect
10 Synthes Craniomaxillofacial (CMF) Distraction System Technique Guide
Distractor Assembly
Use the 1.5 mm/2.0 mm screwdriver blade to reinsert themachine screw into the collar and distractor body and fullytighten, locking the construct together.
Notes– Once the distractor is fully assembled, rotate the activation
hex counterclockwise to verify that the footplates aretranslating and the distractor is functioning properly. Thedistractor will not activate if the collar is not reattached orif the distractor is assembled improperly.
– Return the footplates to the original position by turningthe activation hex clockwise until the footplates reach thecenter of the distractor body.
– When the distractor is fully assembled, the slot on the dis-tractor body will face medially and the screw hole counter-sinks will face laterally.
Final AB distractor assembly with footplates in the home position
Underside of the final AB distractor assembly
screw hole countersinks
slot on the distractor body
Synthes 11
3bAssemble footplates-BC distractor
Instruments
311.005 Screwdriver Handle with hex coupling,small
311.006 Screwdriver Handle with hex coupling,medium
313.252 1.5 mm/2.0 mm Screwdriver Blade,self-retaining, PlusDrive, 96 mm
313.253 1.5 mm/2.0 mm Screwdriver Blade,self-retaining, PlusDrive, 76 mm
Use the 1.5 mm/2.0 mm screwdriver blade to remove themachine screw from the distractor body.
Correct
Incorrect
12 Synthes Craniomaxillofacial (CMF) Distraction System Technique Guide
Distractor Assembly
Insert the B-style footplate into the open end of the distrac-tor body in the correct orientation, as shown.
Note: The screw holes on the B-style footplate should bepositioned so that they point towards the activation hex andnot the open end of the distractor.
Turn the activation hex counterclockwise to engage the B-style footplate with the lead screw. Rotate the activationhex at least 6 full turns to allow room for the C-style foot-plate.
Technique tip: The activation instrument can be used toturn the activation hex.
Synthes 13
Attach the C-style footplate by fitting it over the open end ofthe distractor body.
Use the 1.5 mm/2.0 mm screwdriver blade to reinsert themachine screw into the distractor body and fully tighten,locking the construct together.
Note: Once the distractor is fully assembled, ensure that theB-style footplate is in the “home” position by turning the ac-tivation hex clockwise until the two footplates meet.
When the distractor is fully assembled, the slot on the dis-tractor body will face medially and the screw hole counter-sinks will face laterally.
Final BC distractor assembly with footplates in the home position
Underside of the final BC distractor assembly
screw hole countersinks
slot on the distractor body
14 Synthes Craniomaxillofacial (CMF) Distraction System Technique Guide
Distractor Assembly
4Assemble extension arm (optional)
Instrument
03.315.004 Removal Instrument, for CMF Distractor
Determine if an extension arm will be needed to place theactivation hex in an area easily accessible with the activationinstrument.
Notes– To ensure that the soft tissue does not obstruct the activa-
tion hex during distraction, the next longer size extensionarm may need to be used.
– Extension arms can be removed from the distractor at thestart of the consolidation phase without the need for a surgical procedure (see page 28 for instructions).
collar
Synthes 15
Engage the removal instrument with the hex end of the ex-tension arm.
Rotate the removal instrument collar counterclockwise atleast 16 full turns until the hex pocket of the extension armis exposed.
Technique tip: Maintain constant finger pressure betweenthe extension arm and the removal instrument during thisstep.
Place the distractor body activation hex into the hex pocketof the extension arm.
Rotate the removal instrument collar clockwise until the ex-tension arm closes over the activation hex of the distractorbody, and tighten fully.
Distractor assembly with removable extension arm attached
5Assemble second distractor
For bilateral procedures, repeat steps 1 through 4 to assem-ble a distractor for the contralateral side.
16 Synthes Craniomaxillofacial (CMF) Distraction System Technique Guide
Distractor Assembly
Mandible Body Lengthening
The following surgical technique is an example of an intrao-ral approach with the distractor placed in an anterior orienta-tion with intraoral activation. A similar technique can beused for placing the distractor in a posterior orientation witha percutaneous activation port. The distractor can also beplaced on the mandibular ramus.
1Make incision
Make a mandibular vestibular or a submandibular incision.Elevate the periosteum to expose the mandible.
Synthes 17
Mandible Body Lengthening
2Mark osteotomy
Mark the approximate site of the osteotomy.
3Fit distractor
Place a fully assembled distractor in the intended area to as-sess the patient’s anatomy and determine the approximatelocation of the footplates and extension arm.
Factors to consider include:– Occlusal plane– Tooth buds and roots– Planned vector of distraction– Adequate bone for screw placement– Location of mental nerve– Lip closure– Soft tissue (mucosa) coverage– Location of activation hex
18 Synthes Craniomaxillofacial (CMF) Distraction System Technique Guide
Ideal Acceptable Not preferable
Optional technique: Alignment rods
Instrument
03.315.003 Alignment Rod, for CMF Distractor
Alignment rods can be used throughout the course of surgery to:– Aid in parallel placement of the devices– Indicate the vectors of advancement– Hold the distractors during screw fixation and device
placement
To use the alignment rods, place the open end of the align-ment rod over the distractor body or extension arm.
Synthes 19
Slide the alignment rod sleeve forward until it meets thethreaded portion of the rod and rotate clockwise until therod tightens onto the distractor.
Important: The alignment rods should not be used as lever-age for bending the footplates as this may cause damage tothe distractor bodies.
While parallel placement of the distractors is ideal, this maybe difficult to accomplish considering the patient’s soft tissuecoverage, and could potentially lead to patient discomfort. Aslight convergence of the distraction vector is acceptable toensure patient comfort.
The point of convergence should be farther from the patientfor larger advancements and can be closer to the patient forsmaller advancements.
4Cut and contour footplates
Instruments
03.500.014 Cutting Instrument
03.503.039 Plate Cutter
347.964 Combination Bending Pliers,for 1.0 mm and 2.0 mm plates
391.965 Combination Bending/Cutting Pliers,for 1.0 mm to 2.0 mm plates
Cut the footplates to remove any unnecessary screw holes.
Notes on cutting– Activate the distractor to separate the footplates to aid in
cutting.– Cut the footplates so the cut edges are flush with the dis-
tractor body.
Screws can be placed in the holes superior to the distractorbody in the posterior footplate and in the holes inferior tothe distractor body in the anterior footplate for added sta-bility.
Important: A minimum of three screw holes should remainin each footplate to ensure adequate stability.
Take care to avoid placing screws in tooth buds or roots.
Contour the footplates to the mandible using the combination bending pliers.
20 Synthes Craniomaxillofacial (CMF) Distraction System Technique Guide
Mandible Body Lengthening
5Mark distractor location
Instruments
311.005 Screwdriver Handle with hex coupling,small
311.006 Screwdriver Handle with hex coupling,medium
Optional instruments
397.211 Universal Trocar Handle
397.213 2.0 mm Cannula and Obturator
397.232 Malleable C-Retractor
397.420 2.0 mm Cheek Retractor Blade
397.430 2.0 mm Cheek Retractor Ring
Use the appropriate drill bit and screwdriver blade for thefootplate size selected.
Footplate Drill bit Screwdriversize size blade
1.0 mm 0.76 mm 1.0 mm
1.3 mm 1.0 mm 1.3 mm
1.5 mm 1.1 mm 1.5 mm or 1.5 mm/2.0 mm
2.0 mm 1.5 mm 1.5 mm/2.0 mm or 2.0 mm
Mark the position of the distractor before making the os-teotomy by drilling and/or inserting one appropriate lengthscrew through each footplate.
Do not fully tighten the screws.
Synthes 21
Mandible Body Lengthening
6Perform buccal corticotomy
Unscrew and remove the distractor.
Perform the corticotomy on the buccal side of the mandibleextending into the anterior and posterior borders. This allowsstability of the bone segment during replacement of the dis-tractor.
22 Synthes Craniomaxillofacial (CMF) Distraction System Technique Guide
7Reattach distractor
Instruments
311.005 Screwdriver Handle with hex coupling,small
311.006 Screwdriver Handle with hex coupling,medium
Use the prior selected appropriate drill bit and screwdriverblade for the footplate size selected (see page 21).
Reattach the distractor by aligning the footplates with theholes made previously. Drill and/or insert remaining screws.Fully tighten all screws.
Notes– A minimum of three screws should be inserted through
each footplate to ensure adequate stability.– Depending on patient anatomy and placement of the dis-
tractor, the extension arm can either remain in the intraoralcavity or project through a small percutaneous activationport. If the extension arm remains in the intraoral cavity,care should be taken to ensure that it does not interferewith the patient’s ability to eat.
– Extension arms can be secured below the dentition with aloop of wire attached to orthodontic brackets or to theteeth. The loop should restrict the vertical movement ofthe extension arm without affecting the arms’ ability to ro-tate. This will ensure that the extension arm does not in-terfere with mastication.
Synthes 23
8Complete osteotomy
Complete the osteotomy on the lingual aspect of themandible using an osteotome. Take care to avoid the nerve.
Important: The osteotomy must be complete and the bonemust be mobile. The distractor is not designed or intended tobreak bone and/or complete the osteotomy.
9Confirm device activation
Instruments
03.315.001 Activation Instrument, 1.7 mm
03.315.005 Activation Instrument, 1.7 mm, withU-Joint
Use an activation instrument to engage the activation hex of the distractor or extension arm. Rotate in a counterclock-wise direction, as marked on the handle, to confirm devicestability and verify movement of the mandible. Return thedistractor to its original position.
10Repeat steps for bilateral procedures
Repeat steps 1 –9 on the contralateral side.Close all incisions.
24 Synthes Craniomaxillofacial (CMF) Distraction System Technique Guide
Mandible Body Lengthening
Postoperative Management
Suggested distraction protocol
Instruments
03.315.001 Activation Instrument, 1.7 mm
03.315.005 Activation Instrument, 1.7 mm, withU-Joint
It is recommended to begin active distraction three to fivedays after device placement. For young patients, active dis-traction can begin earlier to prevent premature consolida-tion.
To activate the distractors, engage an activation instrumentwith the activation hex and rotate counterclockwise (in thedirection of the arrow marked on the instrument).
The instrument can be made smaller for use in young pa-tients, by removing the blue machine screw.
Activation instrument
Activation instrument (with blue machine screw removed)
Synthes 25
Rate of activation The AB and BC distractors advance at different rates.
Notes– To accomplish a half-turn, rotate the activation instrument
from the side with the arrow marked on it to the side withthe open slot.
– A minimum of 1.0 mm of linear advancement per day isrecommended to prevent premature consolidation.
1 see Izadi et al., 493 –4992 see Mandell et al., 344 –3483 see Steinbacher et al. 1072 –79
26 Synthes Craniomaxillofacial (CMF) Distraction System Technique Guide
Postoperative Management
1 full turn with activation instrument 0.70 mm of linear advancement 0.35 mm of linear advancement
Recommended number of turns perday based on patient age1, 2, 3
< 1 year old (1.8 mm/day) 2 ½ turns (1.75 mm) 5 turns (1.75 mm)
> 1 year old (1 mm/day) 1 ½ turns (1.05 mm) 3 turns (1.05 mm)
AB distractor BC distractor
Patient careIf the distractors are placed with the extension arms in theintraoral cavity, care must be taken to prevent the arms frominterfering with mastication. Extension arms can be securedbelow the dentition with a loop of wire attached to ortho-dontic brackets or to the teeth. The loop should restrict thevertical movement of the extension arm without affectingthe arm’s ability to rotate. This will ensure that the extensionarm does not interfere with mastication.
If the distractors are placed with the extension arms exitingthrough percutaneous ports, it is important that the exten-sion arms be protected from catching on objects that couldpull or deform the devices and cause the patient pain or in-jury. Extension arms can be taped or bandaged to the skin to prevent them from snagging on external objects.
ConsolidationAfter the desired advancement has been achieved, the newbone must be given time to consolidate. The consolidationperiod should be at least six to twelve weeks.2 This time pe-riod may vary in relation to patient age and should be deter-mined by clinical evaluation.
If the removable extension arms were used, they can be re-moved at the start of the consolidation phase.
Synthes 27
2 see Mandell et al., 344 –348
Extension Arm Removal
Instrument
03.315.004 Removal Instrument, for CMF Distractor
Engage the removal instrument with the extension arm.
Rotate the removal instrument collar counterclockwise atleast 16 full turns. This will unscrew the outer sleeve of theextension arm and expose the hex pocket where the exten-sion arm connects to the distractor.
Warning: When removing the extension arms, rotate onlythe collar of the removal instrument. Do not allow the baseof the removal instrument to rotate in your hand, as doing somay result in a change in the distraction distance that hasbeen achieved.
Disengage the extension arm from the distractor with side-to-side movements of the arm. Remove the extension armthrough the percutaneous port or intraoral cavity.
Note: The line etched on the extension arm corresponds tothe direction of the hex pocket opening at the top of the ex-tension arm. Pushing the extension arm in the direction ofthe line should disengage it from the distractor.
collar
28 Synthes Craniomaxillofacial (CMF) Distraction System Technique Guide
Optional technique
Instruments
03.315.001 Activation Instrument, 1.7 mm
03.315.005 Activation Instrument, 1.7 mm withU-Joint
347.964 Combination Bending Pliers, for 1.0 mmand 2.0 mm plates
If the removal instrument is not available, the extension armscan be removed using an activation instrument and pliers.Engage the extension arm with the activation instrument.While holding the activation instrument still, use the pliers torotate the sleeve on the extension arm counterclockwise atleast 16 full turns to expose the hex pocket where the exten-sion arm connects to the distractor. Disengage the extensionarm from the distractor body with side-to-side movements.
Synthes 29
Device Removal
Instruments
311.005 Screwdriver Handle with hex coupling,small
311.006 Screwdriver Handle with hex coupling,medium
Use the appropriate screwdriver blade for the footplate size used (see table step 5, page 21).
Remove the distractors by exposing the footplates, throughthe same incisions that were used during the initial place-ment surgery, and removing the titanium bone screws.
Note: The distractors are easier to remove if the extensionarms are removed before distractor removal. This will alsohelp keep the intraoral cavity from contacting the externallyexposed extension arm.
30 Synthes Craniomaxillofacial (CMF) Distraction System Technique Guide
1.3 mm
1.5 mm 2.0 mm
1.0 mm 1.3 mm
1.5 mm 2.0 mm
1.0 mm
Footplates– Available in A, B, and C styles to mate with the selected
distractor body. Each footplate is etched with a style letterdesignation
– Available in four sizes: 1.0 mm and 1.3 mm for childrenunder 12 months of age; 1.5 mm and 2.0 mm for olderpatients
– Footplates are used with corresponding size titaniumbone screws
– 2.0 mm footplates accept Synthes 2.0 mm titanium locking screws
– Available in cloverleaf and mesh designs– Symmetrical for use on both sides of the mandible– Material: Commercially pure titanium
A-stylefootplate
B-stylefootplate
C-stylefootplate
Cloverleaf footplates
Mesh footplates
Implants
Synthes 31
Implants
Distractor bodies– Offered in center-translating (AB distractor) and end-trans-
lating (BC distractor) designs – Available with or without a universal joint– Materials: Titanium alloy (Ti-6AI-7Nb) and cobalt
chromium alloy (Co-20Cr-15W-10Ni)
Note: Allergic reactions may occur in patients previously sen-sitised to nickel.
AB distractor bodies – Center-translating distractor bodies work with A-style and
B-style footplates– Both footplates are positioned in the center of the distrac-
tor and move laterally away from one another when thedistractor is activated
– Footplates can be placed more anteriorly on the mandiblewith half of the distractor initially positioned posterior tothe osteotomy
– Available in 15 mm, 20 mm, 25 mm and 30 mm lengths
Collar
Machinescrew
BC distractor body with universal joint
BC distractor body
AB distractor body with universal joint
AB distractor body
A footplate B footplate
Distractor body (lead screw inside)
Activation hex
32 Synthes Craniomaxillofacial (CMF) Distraction System Technique Guide
Rigid extension arm
Flexibleextension arm
Extension arms– Allow the point of activation to be moved away from the
distractor for easier access with the activation instrument– Can be placed intraorally or percutaneously– May be removed during the consolidation phase without a
surgical procedure (see page 28)– Rigid arms available in 20 mm, 40 mm, and 60 mm
lengths, flexible arms available in 30 mm, 40 mm and60 mm lengths
– Materials: Titanium alloy (Ti-6AI-7Nb), cobalt chromiumalloy (Co-20Cr-15W-10Ni) and silicone
Note: Allergic reactions may occur in patients previously sen-sitised to nickel.
BC distractor bodies– End-translating distractor bodies work with B-style and C-
style footplates– Both footplates are positioned at one end of the distractor.
When the distractor is activated, the B-style footplatetranslates down the distractor away from the C-style foot-plate, which remains stationary
– Footplates can be placed more posteriorly on the mandiblewith the distractor body initially positioned either anterioror posterior to the osteotomy, depending on the orienta-tion
– Available in 15 mm, 20 mm, 25 mm, 30 mm, 35 mm and40 mm lengths
Activation hex
C footplate B footplate Distractor body
Machinescrew
Synthes 33
Implants
34 Synthes Craniomaxillofacial (CMF) Distraction System Technique Guide
04.315.000 2.7 mm Titanium Machine Screw, for CMFDistractor, 3 ea.
04.315.001 Removable End Cap, for CMF Distractor,2 ea.
AB Distractor Bodies, End Activated, for CMF Distractor, 2 ea.Length (mm)
04.315.003 15
04.315.004 20
04.315.005 25
04.315.006 30
BC Distractor Bodies, End Activated, for CMF Distractor, 2 ea.Length (mm)
04.315.023 15
04.315.024 20
04.315.025 25
04.315.026 30
04.315.027 35
04.315.028 40
AB Distractor Bodies, End Activated with U-Joint, for CMF Distractor, 2 ea.
Length (mm)
04.315.053 15
04.315.054 20
04.315.055 25
04.315.056 30
BC Distractor Bodies, End Activated with U-Joint, for CMF Distractor, 2 ea.
Length (mm)
04.315.063 15
04.315.064 20
04.315.065 25
04.315.066 30
04.315.067 35
04.315.068 40
Removable Extension Arms, rigid, 2 ea.Length (mm)
04.315.104 20
04.315.108 40
04.315.112 60
Removable Extension Arms, flexible, 2 ea.Length (mm)
04.315.125 30
04.315.127 40
04.315.132 60
1.0 mm Mandible Mesh Feet, for CMF Distractor, 3 ea.Style
04.315.201 A-Type
04.315.202 B-Type
04.315.203 C-Type
1.0 mm Mandible Cloverleaf Feet, for CMF Distractor, 3 ea.Style
04.315.211 A-Type
04.315.212 B-Type
04.315.213 C-Type
1.5 mm Mandible Mesh Feet, for CMF Distractor, 3 ea.Style
04.315.301 A-Type
04.315.302 B-Type
04.315.303 C-Type
1.5 mm Mandible Cloverleaf Feet, for CMF Distractor, 3 ea.Style
04.315.311 A-Type
04.315.312 B-Type
04.315.313 C-Type
2.0 mm Mandible Mesh Feet, for CMF Distractor, 3 ea.Style
04.315.401 A-Type
04.315.402 B-Type
04.315.403 C-Type
Synthes 35
2.0 mm Mandible Cloverleaf Feet, for CMF Distractor, 3 ea.Style
04.315.411 A-Type
04.315.412 B-Type
04.315.413 C-Type
1.3 mm Mandible Mesh Feet, for CMF Distractor, 3 ea.Style
04.315.501 A-Type
04.315.502 B-Type
04.315.503 C-Type
1.3 mm Mandible Cloverleaf Feet, for CMF Distractor, 3 ea.Style
04.315.511 A-Type
04.315.512 B-Type
04.315.513 C-Type
36 Synthes Craniomaxillofacial (CMF) Distraction System Technique Guide
All screws with PlusDrive recess.
1.0 mm Titanium Cortex Screws, self-tapping, 20 ea.Length (mm)
400.404 4
400.406 6
400.408 8
400.410 10
400.412 12
1.2 mm Titanium Emergency Screws, 4 ea.Length (mm)
400.464 4
400.466 6
400.468 8
400.470 10
400.472 12
1.3 mm Titanium Cortex Screws, self-drilling, 20 ea.Length (mm)
400.454 4
400.456 6
1.3 mm Titanium Cortex Screws, self-tappingLenghth (mm) Qty.
400.434 4 10
400.436 6 10
400.438 8 20
400.440 10 10
400.442 12 10
1.7 mm Titanium Emergency ScrewsLength (mm) Qty.
400.484 4 6
400.486 6 6
400.488 8 4
400.490 10 2
400.492 12 2
1.5 mm Titanium Cortex Screws, self-drillingLength (mm) Qty.
400.054 4 10
400.056 6 20
400.058 8 20
1.5 mm Titanium Cortex Screws, self-tappingLength (mm) Qty.
400.034 4 10
400.036 6 20
400.038 8 20
400.040 10 10
400.042 12 10
2.0 mm Titanium Emergency ScrewsLength (mm) Qty.
400.274 4 4
400.276 6 8
400.278 8 8
400.280 10 2
400.282 12 2
2.0 mm Titanium Cortex Screws, self-drillingLength (mm) Qty.
401.061 4 10
401.063 6 20
401.065 8 20
2.0 mm Titanium Cortex Screws, self-tappingLength (mm) Qty.
401.041 4 10
401.043 6 20
401.044 8 20
401.045 10 10
401.046 12 10
Screws
Synthes 37
2.4 mm Titanium Emergency ScrewsLength (mm) Qty.
401.791 5 4
401.792 6 12
401.794 8 12
401.795 10 4
401.796 12 4
2.0 mm Titanium Locking Screws, self-tappingLength (mm) Qty.
401.292 6 20
401.294 8 20
401.295 10 10
401.296 12 10
38 Synthes Craniomaxillofacial (CMF) Distraction System Technique Guide
03.307.002 Silicone Tip Guard
03.315.001 Activation Instrument, 1.7 mm, for CMFDistractor
03.315.003 Alignment Rod, for CMF Distractor
03.315.004 Removal Instrument, for CMF Distractor(For attaching and removing extensionarms)
03.315.005 Activation Instrument, 1.7 mm withU-Joint, for CMF Distractor
Instruments
Synthes 39
311.005 Screwdriver Handle with hex coupling,small
03.500.014 Cutting Instrument, for DistractionFootplates
03.503.039 Plate Cutter for Midface Plates
Instruments
40 Synthes Craniomaxillofacial (CMF) Distraction System Technique Guide
312.154 1.5 mm Threaded Drill Guide, long,for 2.0 mm plates
1.5 mm/2.0 mm Screwdriver Blades,self-retaining, PlusDrive, hex coupling
313.252 96 mm313.253 76 mm
Screwdriver Blades, self-retaining,PlusDrive, hex coupling
313.806 1.3 mm, 76 mm314.485 1.0 mm, 75 mm
Cruciform Screwdriver Blades withSpring Holding Sleeve, hex coupling
314.482 1.0 mm314.491 1.3 mm314.651 1.5 mm314.675 2.0 mm
0.76 mm Drill Bits, Stryker J-latch,for use with 1.0 mm screws
316.114 with 14 mm stop, 44.5 mm 316.150 with 5 mm stop, 44.5 mm 316.180 with 8 mm stop, 44.5 mm
311.006 Screwdriver Handle with hex coupling, medium
Synthes 41
347.964 Combination Bending Pliers,for 1.0 mm and 2.0 mm Plates
1.0 mm Drill Bits, Stryker J-latch,for use with 1.3 mm screws
316.236 60 mm316.446 with 4 mm stop, 44.5 mm316.447 with 6 mm stop, 44.5 mm316.448 with 8 mm stop, 44.5 mm
1.1 mm Drill Bits, Stryker J-latch,for use with 1.5 mm screws
317.140 with 4 mm stop, 44.5 mm317.160 with 6 mm stop, 44.5 mm317.180 with 8 mm stop, 44.5 mm317.220 with 12 mm stop, 44.5 mm316.500 80 mm
1.5 mm Drill Bits, Stryker J-latch,for use with 2.0 mm screws
317.640 with 4 mm stop, 44.5 mm317.660 with 6 mm stop, 44.5 mm317.680 with 8 mm stop, 44.5 mm317.720 with 12 mm stop, 44.5 mm316.510 80 mm
319.520 Depth Gauge, long, for 1.5 mm and2.0 mm screws
42 Synthes Craniomaxillofacial (CMF) Distraction System Technique Guide
347.980 Plate Holding Forceps, for 1.5 mm, 2.0 mmand 2.4 mm plates
Plate Holding Instruments347.986 for 1.0 mm and 1.3 mm plates347.987 for 1.5 mm and 2.0 mm plates
391.952 Cutter for Strut Plates and Mesh Plates
391.965 Combination Bending/Cutting Pliers,for 1.0 mm to 2.0 mm plates
Instruments
Synthes 43
397.213 2.0 mm Cannula and Obturator
397.232 Malleable C-Retractor
397.420 2.0 mm Cheek Retractor Blade
397.430 2.0 mm Cheek Retractor Ring
397.211 Universal Trocar Handle
44 Synthes Craniomaxillofacial (CMF) Distraction System Technique Guide
CMF Distraction System Set(01.315.000)
Graphic Cases, Trays and Modules690.670 Graphic Case, for CMF Distractor690.625 Basic Craniofacial Tray Insert690.657 Orthognathic Trocar Tray Insert690.672 Distraction Instrument Insert Tray,
for CMF Distractor304.071 BC Distractor Body/Extension Arm Module,
for CMF Distractor304.072 1.0 mm/1.3 mm Mandible Module,
for CMF Distractor304.073 1.5 mm Mandible Module,
for CMF Distractor304.074 2.0 mm Mandible Module,
for CMF Distractor304.089 AB Distractor Body Module,
for CMF Distractor304.099 CMF Distractor Label Sheet
Screw Length MarkersScrew Length Markers, 1 pkg. of 10
304.104 4 mm304.106 6 mm304.108 8 mm304.110 10 mm304.112 12 mm
Screw Length Markers, for self-drillingscrews
304.104W 4 mm, 4 ea.304.106W 6 mm, 6 ea.304.108W 8 mm, 4 ea.
Izadi K, Yellon R, Mandell DL, et al. (2003) “Correction of Upper Air-way Obstruction in the Newborn with Internal Mandibular Distrac-tion Osteogenesis.” J Craniofac Surg 14:493-499.
Mandell DL, Yellon R, Bradley J, et al. (2004) “Mandibular Distrac-tion for Micrognathia and Severe Upper Airway Obstruction.” Arch Otolaryngol Head Neck Surg 130:344-348.
Steinbacher D, Kaban L, Troulis M. (2005) “Mandibular Advance-ment by Distraction Osteogenesis for Tracheostomy-Dependent Chil-dren with Severe Micrognathia.” J Oral Maxillofac Surg 63:1072-1079.
Bibliography
Synthes 45
Synthes GmbHEimattstrasse 3CH-4436 Oberdorfwww.synthes.com 0123Presented by: 03
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