Craniomaxillofacial Surgery

The modern version of a mandibular fixation classic

A Rigid External Fixation System

Xternal Fixator

Xternal Fixator

The KLS Martin Xternal Fixator System

The KLS Martin Xternal Fixator can be assembled in two unique configurations.

Indications
The KLS Martin Titanium Xternal Fixator is intended to stabilize and provide treatment
for fractures of the maxillofacial area, including:
mandible fractures

fractures with severe soft tissue compromise

mandible fractures associated with infection fractures in irradiated patients

severely comminuted mandible fractures

panfacial fractures

non-unions

burn maintenance

tumor resections
gunshot wounds

Features
MRI safe construct
Adjustable throughout application

Set Overview
- Configuration 1

clamp

1:1

The KLS Martin Titanium Xternal Fixator creates a rigid

construct using three basic components: 4.0 mm rods, 4.0 mm
fixation screws with 2.7 mm threads, and snap-on, adjustable
clamps.
51-670-04
for use with 51-670-07-11

Implants
Adjustable Clamp
Accepts the 3.2 mm fixation pin and the 4.0 mm
rod on each end of the clamp.
Snap-on design allows additional clamps to be
placed.

pins

1:1

51-673-07

51-673-09

51-673-13

Connects two rods in any orientation.

Maintains the rod position during frame assembly
and fracture reduction.

51-673-17

4.0 mm Titanium Fixation Pin with 2.7 mm thread

Strong, stable fixation.
Biocompatible titanium alloy.
Four thread lengths (7, 9, 13 and 17 mm)
accommodate various soft tissue and bone
thicknesses.
note: Included with the titanium fixation pins is a latex-free tip
guard. This tip guard is autoclavable and allows the surgeon to cover
the end of the pin providing a smooth surface.

4.0 mm Titanium Pre-Bent Rods

1:2

51-672-01
51-672-02

51-672-03

51-672-04

Rods pre-bent to shape of mandible.

Available in 6 sizes.
Can be contoured to match patient anatomy.

51-672-05

51-672-06

51-672-07

Xternal Fixator

Instruments
-not to scale-

Trocar/Cannula, short
50-501-09

Drill Guide/Cannula, long

50-501-29

Rod Template

50-501-19

51-671-28
Facilitates
contouring
the pre-bent
titanium rods.

To protect soft tissue during

insertion of pins or Kirschner
wires.

Ratchet Style
Screwdriver Handle
25-410-00

Cheek Retractor
50-501-10

Rod Bender

Twist Drill

Trocar Handle

Depth Gauge

Screw Cap
Screwdriver

Screwdriver Blade,
X-Fix, 2.0 mm/BOS

50-125-16

50-022-15

50-501-01

50-501-40

51-600-70

51-600-86

For contouring pre-bent

titanium rods.

Surgical Technique
1

Place the patient in maxillomandibular fixation when

appropriate.

Identify the appropriate rod or combination of rods for

fixation. In most cases, the pre-bent rods will not need
additional contouring. If contouring is needed, follow steps
34, otherwise skip to step 5.

Note: If rod needs to be cut, use a large pin cutter. Ensure rod is removed
from patient prior to cutting.
Caution: Ensure that both pieces of the bar are held during bending process.

Contour the Rod Template (51-671-28) on the

patient to match the patients bony anatomy.

Note: Rod should be positioned at least one centimeter from soft tissues.

Using the bender, contour the selected pre-bent rod to

match the rod template.

Verify the fit of the pre-bent rod on the patient. Identify

the desired pin locations for the first and last pin (furthest
from the defect on the proximal and distal side) and mark
accordingly. A minimum of two pins per segment (two
pins in greatest segment and two in other segments) is
recommended to ensure adequate stability. Optimal location
of pins will place one pin a minimum of 10 mm proximal to
the defect.

To insert a pin, make a small incision and dissect the

soft tissue at the first marked pin location.

Xternal Fixator

Surgical Technique

7
(continued)

Insert the cannula (50-501-19) into the trocar handle

(50-501-01). Insert the 4.0 mm trocar (50-501-09 )into the
handle/cannula assembly. Pass the trocar through the stab
incision to the bone. Remove the trocar.

Use the 2.2 mm twist drill (50-022-15) through the

cannula to drill into the bone. Remove drill guide. If using a
self-drilling
pin, load approximately 5 mm of the pin
directly into a Jacobs chuck drill. Using the cannula as a
guide, drive the fixation pin into the mandible, stopping when
the collar on the pin is against the buccal cortex.

Insert the depth gauge (50-501-40) through the

cannula and hook the lingual cortex of the mandible.
Remove the measuring device from the cannula. Insert the
X-Fix pin into the Ratchet Driver (25-410-00) with Triangle
Blade (51-600-86). Ensure ratchet handle is in the forward
position.

10 Select the X-Fix pin with the appropriate length thread.

10A

With clockwise rotation, insert the X-Fix pin through the

cannula until the stop is seated against the buccal cortex,
ensuring proper implant depth.

10B

Surgical Technique

(continued)

11

11

Following steps 610, position and insert the second

pin on the opposite side and furthest from the defect.

12A

12

Snap bar clamp (51-670-05) onto both X-Fix pins

and rod.

12B

13

Reduce the fracture in standard fashion and

tighten the clamp nuts.

14

13

14
Verify the correct alignment prior to proceeding.

Xternal Fixator

Surgical Technique

(continued)

16

15

Attach a third clamp to the rod approximately 10 mm

proximal or distal to the defect in the stable bone segment.

16

Select the appropriate length cannula, based on soft

tissue thickness, and insert the cannula into the clamp as
shown. Angle the cannula and clamp for the desired pin
placement. Mark the incision site. Temporarily rotate the
cannula and clamp upwards to minimize obstruction while
making the incision. Make a small incision and bluntly dissect
the soft tissue. Rotate the clamp and cannula to the original
position. Insert the trocar and pass the cannula through the
incision to the bone. Remove the trocar. Tighten the clamp,
securing the cannula to the rod.

17A

Note: Do not overtighten the clamp as this will result in damage to

the cannula.

17

17B

Insert a pin as outlined in steps 816. Loosen the

clamp slightly and slide the cannula off of the X-Fix pin. With
the clamp capturing the pin and the rod, tighten the clamp
nut.

18

Insert all remaining pins to complete the frame, as

outlined in previous steps.
Note: A minimum of two pins are required on each side of the
defect.

18

19

Verify reduction and alignment. If adjustment is

needed, loosen the clamp nuts, manipulate the mandible,
and retighten the clamps.

20

Place tip guards, if desired, to prevent pins from

catching on skin and clothing.

19

Alternative Frame Configuration

One-half frame
- as applied on an infected angle fracture

Modular frame
- as applied on a comminuted fracture. A modular
frame can be created depending on fracture location.

Xternal Fixator

The KLS Martin Xternal Fixator is an easy-to-use system for mandibular

fractures and defects with minimal incisions.
- Configuration 2

System benefits:
Easy to apply

Lower cost fixation option

Self-drilling pins

Limited internal hardware

Titanium pins and washers

Extremely stable 3.2 mm pin

3 different thread lengths of 7 mm,

11 mm, and 13 mm

The KLS Martin Mandibular Xternal Fixator is intended to

stabilize fractures and defects including:
mandible fractures
mandible fractures associated with infection
severely comminuted mandible fractures
non-unions
tumor resections
gunshot wounds

fractures with severe soft tissue

compromise
fractures in irradiated patients
panfacial fractures
burn maintenance
bone grafting defects

11

Instruments
- not to scale

X-Fix Carbon Fiber Rod

51-601-03

X-Fix Screw Cap

X-Fix Connection Bar

51-670-01

51-670-02

100 mm, 4 mm dia

X-Fix Carbon Fiber Rod

51-601-07

150 mm, 4 mm dia

X-Fix Acrylic Mold

51-671-27

Tray for X-Fix, w/Lid

55-969-45

Twist Drill

Twist Drill

50-022-15

50-126-06

115 mm, 2.2 mm dia, 105 mm, 2.5 mm dia,

w/notch, Level I System
w/notch

Screwdriver,
X-Fix Standard

Screwdriver,
X-Fix Screw Cap

51-600-65

51-600-70

30 cm X 45 cm

X-Fix Pins
51-670-07

51-670-11

51-670-13

Xternal Fixator

Surgical Technique
1

Depending on the size of the fracture or defect, the

appropriate number of pins (51-670-07, 51-670-11, 51-67013) can be placed on either side of the unreduced fracture.
A minimum of 2 per side is required. Using the 2.5 mm twist
drill, create a pilot hole for the X-Fix pins. The trocar and drill
guide can be used to place the pins. Use the pin driver to
screw the pins into the bone.

Place one X-Fix Connection Bar (51-670-02) on either

side of the fracture. Tighten with Hex Head Driver (51-60065).
WARNING: X-Fix Connection Bars are manufactured from stainless

steel. They must be removed prior to MR Imaging.

Place the carbon rod in X-Fix connection bar on one

side of fracture and tighten in place. Reduce fracture and
tighten carbon bar in place on opposite side of fracture. This
creates a stable reduction.

The correct size for the acrylic splint is determined by

anatomy and fractures. Once determined, the X-Fix Acrylic
Mold (51-671-27) is adjusted to the appropriate size. Pour
the acrylic mixture in the mold.
-See additional instructions for acrylic mixing on page 14.
-If using plastic tube instead of molding tray see instructions
on page 14.

13

Using the X-Fix Screw Cap Screwdriver, (51-600-70)

place one Screw Cap (51-670-01) on the threaded portion of
each pin. The flat side should be showing.

The acrylic can be removed from the tray when it is a

putty-like consistency. The acrylic is placed over the pin
threads against the screw washer. Do not place the outer
screw cap immediately; this may weaken the acrylic bar.
Place the screwcaps only when acrylic has hardened.

Using the X-Fix Screw Cap Screwdriver (51-600-70)

tighten an additional screw cap against the acrylic. Once the
acrylic has hardened, the carbon bar and connection bar can
be removed.

Place tip guard, if desired, to prevent pins from catching

on skin and clothing.

Xternal Fixator
The Acrylic Splint:

There are two techniques to make acrylic splints; using either the molding tray or a plastic tube.
The tray creates a rectangular shaped acrylic bar with the acrylic exposed to the elements. The second
technique uses a plastic tube (endotracheal or chest) placed over the pins and then filled with acrylic.
This technique provides a smoother exterior surface.

Acrylic:

An autopolymerizing denture acrylic or orthodontic acrylic can be used to form the bar. The liquid
and powder are mixed according to the manufacturer's specifications. Many of these acrylics are mixed in
a ratio of one cc of liquid to three ccs of powder. It is convenient to have powder and liquid pre-measured
and kept in small individual containers. A bottle holding approximately 8 ccs of liquid and another bottle
holding approximately 24 ccs of powder will create a bar long enough for any single application. Doubling
this amount will make a bar of ample length for any bilateral application.

Acrylic Mixing:

The powder is poured into the liquid in a container of ample size. The creamy mass is stirred
for a minute to insure even mixing. This is allowed to stand for two to three minutes depending on the
temperature of the room. The ideal consistency of the powder/liquid acrylic mixture will depend on the
technique used for bar formation.

Molding Tray Technique:

When using the molding tray, the acrylic consistency should be pliable. To prevent sticking,
petroleum jelly can be smeared into the bar-forming tray. The putty-like acrylic mass is placed into a tube
and pressed into the take-apart mold. The acrylic bar is formed into the mold and the excess removed by
hand pressure. Four to five minutes may elapse from the time of mixing until the period of bench curing
has been accomplished.
After approximately 5 minutes, the still pliable plastic bar is carefully removed from the take-apart
mold without deforming its shape.
While still semi-soft, the acrylic bar is pressed onto the machine threads of the bone screws. Care
should be taken to avoid over-thinning the bar. Ensure adequate protrusion of the threaded screw through
the acrylic for placement of the screw caps.
The acrylic bar should be kept away from contact with the skin, as the heat from polymerization
can cause tissue damage. Wet sponges can be placed under the bar to protect the skin.

15
Plastic Tube Technique:
 When using the plastic tube, the acrylic should be more liquid. The chest tube is cut to length and
fit over the screws. Cut an x through both sides of the tube where the pins will be placed. Cut one hole
and place the tube over the pin before the next hole is marked and cut. This process is continued until
all necessary holes are cut. Once all the holes are cut, the tube is placed over the pins to confirm proper
placement.
The acrylic can be placed in the tube in 2 different ways. If the tube is placed over the pins, the
tube can be filled in place using a syringe. Depending on the length of tube, a plastic syringe can be
selected that will hold an adequate amount of acrylic to fill the tube. The tip of the syringe may be trimmed
to facilitate tight placement into the end of the tube. The acrylic is mixed and loaded into the syringe. The
acrylic is then injected into the plastic tube from one end all the way to the other. If the acrylic stiffens or
begins to set, or if the distance is too great to push the acrylic through the entire tube from one end, a
second acrylic mix may be required from the opposite side. Filling the tube from both ends may make
filling the tube easier and faster. If the acrylic is inserted from both ends of the tube, place a small bore
needle into the center of the tube near the mid line to allow any air bubbles to escape. If it is desired to
fill the tube off of the pins, simply remove the tube from the pins and insert the syringe into the tube filling
with acrylic. Tape can be placed over the pin holes to keep acrylic from seeping out.
The screw caps are placed on the machine-threaded end of the bone screw and initially twisted just
slightly. Final tightening is accomplished when the heat of polymerization has dissipated (approximately
five minutes later). Avoid over tightening the screw caps while the acrylic is soft, as this may thin and
weaken the acrylic bar at these locations.
Once the acrylic is set, the acrylic will return to room temperature. All heat will have dissipated. The
screw caps are securely tightened and the primary or mechanical splint is removed. This is accomplished
by removing it in the reverse order that it was applied.
The rigid, light acrylic bar provides rigid fixation until the fracture site, bone graft, or soft
tissue envelope is healed. When properly placed and maintained, the external fixator can maintain its
biomechanical stability for periods exceeding nine months.

Sterilization Information
The KLS Martin Xternal Fixator is a non-sterile, single use device.
All titanium, carbon fiber and stainless steel components are steam sterilizable.

Sterilization by User
The following parameters are recommended:
For pre-vacuum cycles, a 4-minute exposure time at 270F.
Caution: Time required for sterilizer to reach temperature is not included in the times given.
This is based on instructions in Steam Sterilization and Sterility Assurance in Health Care
Facilities (ANSI/AAMI ST46-2002-5.8.1 and 5.8.2.)

Additional Literature
Xternal Fixator

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20

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Craniomaxillofacial Surgery

patient-specific pre-surgical planning models

Transport

ClearView

Anatomical Models

The ClearView modeling line is truly state-of-the-art.

These extremely accurate stereolithography models

allow for intra-operative use because they are
produced in a novel sterilizable material. Selective
coloration is provided to aid in visualization of vital
structures such as tooth roots or tumor masses.
Contact us for more information about using
modeling on your next case.

ClearViewTM Anatomical Models allow for:

Pre-surgical simulation of complex
reconstructive surgeries
Bending of distraction devices or
plates prior to surgery
Intra-operative use of the model
once sterilized using flash autoclave
Selective coloration to aid in
visualization of vital structures such as
tooth buds, the inferior alveolar nerve
canal, tumor masses and fibrous dysplasia

Distraction Product Overview

OSTEOVIEW

MODELS
NOW AVAILABLE

Surgical Innovation is our Passion

v3 02.15.06

v12.2 07.16.07

Distraction Product
Overview

Instrument Catalog

Anatomical Models

P.O. Box 16369 Jacksonville, FL 32245 Tel. 904.641.7746 800.625.1557 Fax 904.641.7378

www.klsmartin.com
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98 - Xternal Fixator
v3.1 09.21.2009