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Surgical Technique Biomet ® Vision Unilateral Fixator

Biomet Vision Unilateral Fixator - Hip · Clamp (Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp • All telescoping fixator

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Page 1: Biomet Vision Unilateral Fixator - Hip · Clamp (Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp • All telescoping fixator

Surgical Technique

Biomet® Vision™

Unilateral Fixator

Page 2: Biomet Vision Unilateral Fixator - Hip · Clamp (Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp • All telescoping fixator

Contents

Introduction................................................. Page 1

Design Features ........................................... Page 7

Instruments ................................................. Page 8

Standard Fixator Technique ......................... Page 9

Arc Clamp With Standard ............................ Page 15Fixator Technique

Ankle Fixator And Variable Ankle ................. Page 16Fixator Technique

System Assembly/Disassembly................... Page 22

Suggested Screw Site Care/Sterilization ..... Page 24

Product Information .................................... Page 25

Further Information ..................................... Page 29

Page 3: Biomet Vision Unilateral Fixator - Hip · Clamp (Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp • All telescoping fixator

1

Introduction

The Biomet Vision Unilateral Fixator is an external fixation

device intended for use in the treatment of bone conditions

including leg lengthening, osteotomies, arthrodesis and

fracture fixation addressing periarticular, diaphyseal and

other fractures amenable to temporary or definitive external

fixation.

The Biomet Vision Unilateral Fixator incorporates

lightweight carbon fiber materials into its frame to allow

for unobstructed fracture visualization and provide optimal

fixation. The system includes multiple frame configurations

- the Standard Fixator, Ankle Fixator, Variable Ankle Fixator

and Arc Clamp with Standard Fixator - that all share a

unique carbon central body design. The radiolucent central

body includes serrated rotational and dual locking

connectors with locking connector bolts that provide a

mechanical locking mechanism with up to 120° of

controlled fracture reduction in any plane.

Page 4: Biomet Vision Unilateral Fixator - Hip · Clamp (Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp • All telescoping fixator

Introduction (Continued)

Standard Fixator Complete (Catalog #20150)

The standard fixator is comprised of a telescoping fixator

clamp (female), fixed clamp (female), two dual locking

connectors and two rotational locking connectors (male).

The telescoping fixator clamp and fixed clamp are coupled

to a rotational locking connector and secured by means

of locking setscrew. The two dual locking connectors are

coupled together with opposite ends connecting to a

rotational locking connector. Rotational locking connectors

and dual locking connectors are coupled together by

means of a locking connector bolt. Each component is

secured using a torque wrench.

Telescoping Fixator Clampwith CD Mechanism (1 each)

Rotational Locking connectors(2 each)

Locking Connector Bolt (3 each)

Dual Locking Connector (2 each)

Fixed Clamp (1 each)

2

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3

Ankle Fixator Complete (Catalog #20380) And Variable

Ankle Fixator Complete (Catalog #20390)

The ankle and variable ankle fixator are comprised of a

telescoping fixator clamp (female), ankle clamp (female),

two dual locking connectors and two rotational locking

connectors (male). The telescoping fixator clamp and

ankle clamp are coupled to a rotational locking connector

and secured by means of locking setscrew. The two dual

locking connectors are coupled together with opposite

ends connecting to a rotational locking connector.

Rotational locking connectors and dual locking connectors

are coupled together by means of a locking connector

bolt. The ankle clamp pivot bolt is locked in the direction

of the yellow arrow etched on the clamp. The telescoping

fixator clamp and central body component should be

parallel to the long axis of the tibia medially. Positioning

the fixator in this fashion will ensure free excursion of the

telescoping fixator clamp and provide for predictable

intra-operative adjustments.

Telescoping Fixator Clampwith CD Mechanism (1 each)

Rotational Locking connectors(2 each)

Variable Ankle Fixator complete offers a variable positiontalar pin clamp that provides increased flexibility whenapplying the ankle fixator to the patient.

Locking Connector Bolt (3 each)

Dual Locking Connector (2 each)

Ankle Clamp

Page 6: Biomet Vision Unilateral Fixator - Hip · Clamp (Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp • All telescoping fixator

Introduction (Continued)

Arc Clamp (Catalog #20300) With Standard Fixator

Complete (Catalog #20150)

The arc clamp is packaged separately and used in

conjunction with the standard fixator. It can be substituted

for either a telescoping fixator clamp or fixed clamp. The

rotational locking connector (male) attaches to the female

coupler of the arc clamp and is secured by means of a

locking setscrew and torque wrench. The arc clamp has

two silver template clamps (shown on pg. 15) to allow use

of soft tissue instrumentation during bone screw application

and two black bone screw clamps for securing bone

screws. All locking components are secured with the

torque wrench.

Telescoping Fixator Clampwith CD Mechanism (1 each)

Rotational Locking connectors(2 each)

Locking Connector Bolt (3 each)

Arc Clamp

Black bone screwclamps

Dual Locking Connector (2 each)

4

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5

Individual Frame Components

Dual Locking Connectors

• Two dual locking connectors are coupled together by means of a locking connector bolt

• Contain serrated discs at each end of the component, which interface with the serrated discs of therotational locking connectors

• Serrated discs provide 60° of articulation from neutral in any plane (120° total)

Rotational Locking Connectors

• Two rotational locking connectors are coupled to a dual locking connector by means of the lockingconnector bolt

• Contain a single serrated disc at one end of the component and a male rotational coupler at the other end

• Rotational coupler (male) can interface with multiple female coupler components

• Provides 360° of rotation about the axis of the fixator

• Serrated disc interface with the dual locking connector and will accommodate 60° of articulationfrom neutral in any plane (120° total)

• All locking components are definitively secured using a torque wrench

Fixed Clamp

• Fixed clamp (female) is coupled to a rotational locking connector (male) of the Standard Fixator Complete only

• Locking points include two clamp cover locking bolts and one locking setscrew

• Two clamp cover locking bolts secure bone screws to the clamp

• Single locking setscrew secures the fixed clamp to the rotational locking connector

• All locking components are definitively secured using a torque wrench

LockingSetscrew

Clamp CoverLocking Bolts(2 each)

Page 8: Biomet Vision Unilateral Fixator - Hip · Clamp (Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp • All telescoping fixator

Introduction (Continued)

Telescoping Fixator Clamp

• Comprised of a pre-assembled compression/distraction(C/D) mechanism, telescoping fixator clamp cover,locking setscrews, clamp cover locking bolts andstraight clamp

• Coupled to the rotational locking connector (male) of the Ankle, Variable Ankle and Standard Fixators

• Provides up to 4.5cm of compression/distraction over the straight clamp when positioned parallel tothe long axis of the bone

• Locking points include two clamp cover locking bolts and four locking setscrews

• Two clamp cover locking bolts secure bone screws to the clamp

• Three of the four locking setscrews secure the telescoping fixator clamp cover to the straight clampand the remaining locking setscrew secures thestraight clamp to the rotational locking connector

• Telescoping fixator clamp cover can be removed for application of MRI Safe SLM Rapid Rod-to-ScrewClamp (Catalog #14605) or MRI Safe SLM RapidRod-to-Rod Clamp (Catalog #14600) directly to theStraight Clamp

• All telescoping fixator clamp locking components are definitively secured using a torque wrench

CD mechanism

Telescoping FixatorClamp cover

Locking Setscrews(4 each)

Clamp Cover LockingBolts (2 each)

Straight Clamp

Distractionlimit

Catalog #14605

Total length =4.5cm

Straight Clamp shown with telescopingfixator clamp cover removed

Each line =2mm

6

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7

Design Features

• Carbon fiber components are radiolucent, strong andlightweight

• Unique central body design permits controlledfracture reduction in any plane

• System is completely modular, allowing for a varietyof frame configurations that address periarticular anddiaphyseal applications

• Serrated locking connectors provide a mechanicallocking mechanism with up to 120° of articulation inany plane

• Universal Application - Ability for fixator to be usedon either the right or left side of body

• New Telescoping Fixator Clamp cover can beremoved for application of Biomet Vision Pin-to-Barto Straight Clamp

• New Variable Ankle Fixator complete offers a variableposition talar pin clamp that provides increasedflexibility when applying the ankle fixator to thepatient

Page 10: Biomet Vision Unilateral Fixator - Hip · Clamp (Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp • All telescoping fixator

Instruments

The following instrumentation is recommended for use

with the Biomet Vision Unilateral Fixator.

NOTE: The use of a Torque Wrench (90in-lbs) is required

to ensure proper locking of the system. Use of traditional

5mm Allen Wrench or T-Wrench is prohibited, as this may

result in undue stress to the carbon fiber materials

4mm T-Wrench (provisional tightening) Catalog #21020

Required when tightening the pivot bolt on Ankle Clamp

and Variable Ankle Clamp.

L-Torque Wrench: Catalog #21030Used for definitive tightening locking connector bolts,locking setscrews and clamp cover locking bolts.

Additional Instrumentation

T-Wrench for bone screws: Catalog #03125

5mm Allen Wrench: Catalog #03110

4mm Allen Wrench: Catalog #02555

4mm hex

4mm hex

5mm hex

4mm hex

Bullet Wrench(Provisional tightening)Catalog #21015

8

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9

Standard Fixator Technique

Step #1

Pre-operative planning is recommended prior to the

application of this device. Assess potential screw site location

based on available bone stock and soft tissue considerations.

Additional modules may be utilized for horizontal screw

placement or fracture specific applications. Selected screw

sites must accommodate the length of the central body

components. All constructs should include at least one

telescoping fixator clamp that should be positioned parallel

to the long axis of the bone to which it is to be secured. Axial

alignment of the telescoping fixator arm helps assure free

excursion (compression/distraction). Fixator components are

used as templates. Prep and drape in routine fashion.

Figure 1

Step #2

Obtaining a preliminary reduction is recommended.

Templating with the fixator body, adjust the rotational locking

connector to avoid limb interference with bolts. Add or

remove knuckles to gain length or accommodate unusually

short limbs. The first bone screw is generally inserted in the

shortest or most difficult fragment. Assess available bone

stock for desired screw position. (Figures 1 & 2)

NOTE: When possible, allow 4cm of distance between

fracture site and first bone screw.

Figure 2

Step #3

A 1cm incision is made and blunt dissection continued to

bone. (Figure 3)

Figure 3

Page 12: Biomet Vision Unilateral Fixator - Hip · Clamp (Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp • All telescoping fixator

Standard Fixator Technique (Continued)

Step #4

The trocar and appropriate length soft tissue guide are then

utilized to identify the center of the bone and to establish the

orientation of the screw tract to be pre-drilled. The orientation

of the insertion of the bone screws should be perpendicular

to the long axis of the bone. (Figure 4) Site of proximal

screws is predicated by the proximal screw clamp. Place the

fixator over the proximal limb area and template all screws

outside the zone of soft tissue injury to prevent contamination

of fracture through the screw

NOTE: Allow a minimum of 4cm of distance between fracture

site and first bone screw.

Figure 4

Step #6

The soft tissue guide is tapped with a mallet to engage the

soft tissue guide with bone. (Figure 5)

Figure 6

Step #7

Insert appropriate drill guide into the soft tissue guide.

(Figure 6)

NOTE:

Drill Guide Drill Bit Screw

4.8mm 4.8mm 6/5mm (Cortical)

3.2mm 3.2mm 6/5mm (Cancellous)

3.2mm 3.2mm 4.5/3.5mm (Cortical)

2.9mm 2.9mm 3.5/3.2mm (Cortical)Step #5

Once the screw site is selected use gentle pressure to

maintain contact between the soft tissue guide and the cortex

of the bone. Extract the trocar.

Figure 5

10

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11

Step #8

Insert matching drill bit with drill stop into the drill guide. Drill

the near cortex. Drilling is halted upon contact with the far

cortex. Be sure pre-drilled screw tract is perpendicular to the

long axis of the bone. (Figure 7)

Figure 8

Step #10

After bi-cortical penetration of the drill, the drill bit and drill

guide are withdrawn. Maintain contact and position of the soft

tissue guide.

Figure 10

Step #11

The appropriate length screw is then inserted through the soft

tissue guide. The bone screw T-Wrench (Catalog #03125) is

used to advance the screw into bone. To obtain optimal

purchase, all bone screws must be bi-cortical with no less

than 2mm protruding from the far cortex and about 5mm

remaining outside the near cortex. Image intensification is

utilized to confirm depth of penetration. (Figure 10)

For short segment, clamp bone screw holes 1 & 3, 3 & 5 or 2

& 4 may be selected. Translocation of clamp on pin cluster is

possible (as necessary).

NOTE: Care must be taken to avoid over-penetration. Due to

the tapered design bone screws must not be backed out or

they will lose purchase.

Step #9

Upon contact with the far cortex, the drill stop is re-positioned

and secured approximately 5mm from the base of the drill

guide. The drill stop will prevent over penetration of the drill

bit into underlying soft tissue structures. The far cortex is then

drilled. (Figures 8 & 9)

Figure 9

Figure 7

Page 14: Biomet Vision Unilateral Fixator - Hip · Clamp (Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp • All telescoping fixator

Standard Fixator Technique (Continued)

12

Step #12

Loosen the clamp cover locking bolts of the fixed clamp such

that the soft tissue guide and existing bone screw are

accommodated. At this point, a second bone screw may be

introduced into the same female clamp to insure a parallel

relationship of the fixed clamp to bone. Repeat steps 3-11

making sure to snug down the female clamp cover locking

bolts to prevent toggle of the soft tissue guides within the

clamp. This helps maintain proper bone screw alignment.

(Figure 11)

Step #13

It is also possible at this point to address the opposing bone

screw cluster. The locking connector bolts and locking

setscrews are provisionally tightened. Proceed to opposite

telescoping fixator clamp. Identify and secure screw

placement following steps 3-11. Align telescoping fixator

clamp and fixed clamp such that they are parallel to the long

axis of the bone into which they are inserted. Insert soft

tissue guide and trocar, snug down clamp cover locking bolts,

and proceed with subsequent bone screw insertion steps 3-11.

(Figure 12)

Figure 13

NOTE: Ensure at least1cm of space isbetween telescopingcover and straightclamp.

Step #14

Remove soft tissue guides and tighten clamp cover locking

bolts providing at least 3cm clearance between fixator body

and skin surface. (Figure 13)

Use of a Torque Wrench (90 in-lbs) is required to ensure proper locking of the system. Use of traditional 5mm AllenWrench or T-Wrench is prohibited, as this may result in undue stress to the carbon fiber materials. (Figure 14)

Figure 14

NOTE: Ensure at least 3cmclearance between fixatorbody and skin surface

Figure 11

Figure 12

Page 15: Biomet Vision Unilateral Fixator - Hip · Clamp (Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp • All telescoping fixator

Figure 16

Figure 19

13

Step #15

Final reduction may be addressed systematically. Length is

accomplished by distracting (manually or incrementally) the

CD mechanism from the telescoping fixator clamp in the

direction of the arrow, counterclockwise. (Figure 15)

NOTE: For angular or translational adjustments there should

be a corresponding adjustment in length.

Figure 15

Turn counterclockwise to distract

NOTE: If distraction (orcompression) is desired, theproximal locking setscrew must firstbe definitively tightened with atorque wrench.

NOTE: If distraction (or compression)is desired, ensure the two distallocking setscrews are NOT definitivelytightened. Upon desired distraction,lock the setscrews with a torquewrench.

Step #16

Rotation about the axis of the fixator may be achieved by

releasing the locking setscrew of the rotational locking

connectors (male). (Figure 16)

Step #17

Each dual locking connector will provide angular adjustments

in two planes relative to fixator position as applied to the

bone. Utilize the dual locking connector most adjacent to

fracture for angular corrections. (Figures 17 & 18)

Step #18

Translational adjustment is performed by releasing two

opposing dual locking connectors in the same plane as

desired correction. Translation can also be addressed by

utilizing the half pins already inserted into the bone to be

translated. (Figure 19)

Figure 17

Figure 18

Page 16: Biomet Vision Unilateral Fixator - Hip · Clamp (Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp • All telescoping fixator

Standard Fixator Technique (Continued)

14

Standard Fixator shown with Straight Clamp and SLM

Rapid Rod-to-Screw Clamps (Cat #14605) applied.

NOTE: CD Mechanism cannot be used for this construct.

Optional Standard Fixator Technique Configurations

MRI SAFE SLM Rapid Rod-to-Screw Clamps can be applied

to opposite ends of the Straight Clamp.

Page 17: Biomet Vision Unilateral Fixator - Hip · Clamp (Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp • All telescoping fixator

Arc Clamp With Standard Fixator Technique

15

The arc clamp may be substituted for either a telescoping

fixator clamp or a fixed clamp component from the Standard

Fixator, where horizontal bone screw placement is desired.

Attach the arc clamp (female) coupler to the rotational locking

connector (male) and secure the single locking setscrew with

a torque wrench.

The arc clamp offers two silver template clamps (Figure 20)

to allow for soft tissue instrumentation during bone screw

application. Additionally, the two black bone screw clamps

will secure the bone screws.

The arc clamp should be applied following steps 3-11 (page

9-11) from Standard Fixator Technique. Assess selected

diaphyseal screw sites to assure a parallel relationship

between telescoping fixator clamp (or fixed clamp) and the

bone. Insert diaphyseal bone screws following steps 3-12

(page 9-12) from Standard Fixator Technique. Obtain

reduction and definitively tighten all fixator-locking bolts with

a torque wrench.

NOTE: Use of a Torque Wrench (90in-lbs) is required to

ensure proper locking of the system. Use of traditional 5mm

Allen Wrench or T-Wrench is prohibited, as this may result

in undue stress to the carbon fiber materials.

Optional Arc Clamp Technique Configuration

Arc Clamp frame shown with Straight Clamp and SLM Rapid

Rod-to-Screw Clamps (Cat #14605) applied.

NOTE: CD Mechanism cannot be used for this construct.

Figure 20

Alternatively, a VariableAngle Screw Clamp can beaffixed to bone screw.

Page 18: Biomet Vision Unilateral Fixator - Hip · Clamp (Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp • All telescoping fixator

Step #1

After achieving a preliminary pre-op reduction, the first screw

to be introduced should be positioned medially in the talar neck,

so that it is parallel to the dome of the talus following steps 3-9

(pages 9-11) of Standard Fixator Technique. (Figure 21)

NOTE: If using Variable Ankle Fixator, reference pg. 20 for first

screw insertion detail

Step #2

After bi-cortical penetration, release the 3.2mm drill bit and

evaluate its position fluoroscopically to confirm a parallel

relationship to the talar dome. Reattach drill bit to drill and

extract. After bi-cortical penetration of the drill, the drill bit and

drill guide are withdrawn. Maintain contact and position of the

soft tissue guide.

Step #3

Attach the ankle clamp onto the talar bone screw and screw

guide with the window of the device positioned medially and

anterior to facilitate lateral radiographic evaluation. Clamp cover

locking bolts of the ankle clamp must be facing distally for

access to locking components. (Figure 22)

Step #4

Using the ankle clamp as a template, select second screw

position in the calcaneus allowing for desired plantar/dorsi

flexion. Repeating steps 3-11 (pages 9-11) of Standard Fixator

Technique, insert second bone screw. Confirm bone screw

position and depth of penetration utilizing image

intensification. (Figure 22)

Step #5

Spatially relocate the talus under the tibia and position

remaining bone screws through the telescoping fixator arm in

the tibial diaphysis perpendicular to the long axis of the tibia.

Secure clamp cover locking bolts (Figure 23) with a torque

wrench for definitive tightening.

Ankle Fixator And Variable Ankle Fixator Technique

16

Figure 23

Figure 22

NOTE: Clamp Cover Locking Bolts must face distal

Figure 21

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17

Step #6

Attach fixator body to ankle clamp. The ankle clamp (female)

coupler is fully seated into the rotational locking connector

(male). These components are assembled and secured by

means of a locking setscrew and torque wrench. (Figure 24)

Step #7

Attach telescoping fixator clamp to central body. Insert soft

tissue guides and drill guides, following Standard Fixator

Technique steps 3-12 (pages 9-12). (Figures 25 & 26)

NOTE: Ensure at least 3cm clearance

between fixator body and skin surface

Figure 24

Figure 25

Male Female

Figure 26

NOTE: Bone screws shown inserted

Page 20: Biomet Vision Unilateral Fixator - Hip · Clamp (Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp • All telescoping fixator

Ankle Fixator And Variable Ankle Fixator Technique (Continued)

18

Use of a Torque Wrench (90in-lbs) is required to ensure

proper locking of the system. Use of traditional 5mm Allen

Wrench or T-Wrench is prohibited, as this may result in

undue stress to the carbon fiber materials. (Figure 27 & 28)

Figure 27

Figure 28

NOTE: If distraction (or compression)is desired, the proximal lockingsetscrew must first be definitivelytightened with a torque wrench.

NOTE: If distraction (or compression)is desired, ensure the two distallocking setscrews are NOT definitivelytightened. Upon desired distraction,lock the setscrews with a torquewrench.

Step #9

Final reduction may be addressed systematically. Length is

accomplished by distracting (manually or incrementally) the

CD mechanism from the telescoping fixator clamp in the

direction of the arrow, counterclockwise. (Figure 29)

NOTE: For angular or translational adjustments there should

be a corresponding adjustment in length.

Figure 29

Turn counterclockwise to distract

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19

Step #10

The pivot bolt on the ankle clamp is tightened in the direction

of the yellow arrow etched on the clamp with use of the 4mm

T-Wrench (Catalog #21020) only. (Figure 30)

NOTE: For left application, tighten counterclockwise, as shown

(Figure 31). For right application, tighten clockwise.

This is the only portion of the ankle clamp that requires use

of a 4mm T-Wrench (Catalog #21020) for definitive tightening.

Do not use the Torque Wrench to tighten.

NOTE: (Cortical Screws placed in Cancellous Bone) When

placing a cortical screw into the neck of the talus, you will

start with a soft tissue sleeve and a 3.2mm drill guide placed

in the appropriate location on the neck of the talus. Under

power a 3.2mm drill bit will be drilled through the medial

cortex and through the lateral cortex. Next, remove the

3.2mm drill sleeve and replace it with a 4.8mm drill sleeve.

Under power a 4.8mm drill bit will be used to drill through

the medial cortex only. The 4.8mm drill sleeve is removed

and the appropriate 6/5mm cortical bone screw is inserted

into the soft tissue sleeve. The screw is inserted past the

lateral cortex by two threads. The talus and calcaneus portion

of the ankle clamp is attached to the screw that is in place

in the neck of the talus. A soft tissue sleeve and 3.2mm drill

sleeve is placed in the calcaneus part of the ankle clamp and

the procedure is repeated in the calcaneus.

Figure 30

Figure 31

Page 22: Biomet Vision Unilateral Fixator - Hip · Clamp (Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp • All telescoping fixator

Ankle Fixator And Variable Ankle Fixator Technique (Continued)

20

Variable Ankle Fixator Complete (Catalog #20390)

Offers a variable position talar pin clamp that provides

increased flexibility when applying the ankle fixator to the

patient. (Figure 32)

Vision Unilateral Ankle Fixator Post-Operative X-Rays

Figure 32

25°

25°

0°Neutral

Variable ball joint

M/L Plane

A/P Plane

The Variable Ankle Fixator ball joint provides 50° cone of angulations.From neutral position, the ball joint provides 25° angulations.

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21

Variable Ankle Fixator shown with MRI SAFE SLM Rapid

Rod-to-Screw Clamps (Cat #14605) and MRI SAFE SLM

Rapid Rod-to-Rod Clamp (Cat # 14600) applied to Straight

Clamp.

NOTE: CD Mechanism cannot be used for this construct.

Ankle Fixator shown with Straight Clamp and MRI SAFE SLM

Rapid Rod-to-Screw Clamps (Cat #14605) applied.

NOTE: CD Mechanism cannot be used for this construct.

Page 24: Biomet Vision Unilateral Fixator - Hip · Clamp (Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp • All telescoping fixator

System Assembly/Disassembly

22

The Biomet Vision Unilateral Fixator is shipped fully assembled,

but can be adjusted to accommodate a desired length.

Removing A Dual Locking Connector

• To remove a dual locking connector, two locking bolts must be fully removed

• While removing the locking bolts, components should not be held together, but rather should be apart so that threadsare only engaged with a single component at a time

• With the two locking bolts removed the dual locking connector is put aside and the frame can be reassembled

• To reassemble the frame, the locking bolt should be fully threaded through the remaining dual locking connector before it engages the threaded component of the rotational locking connector or dual locking connector

• By fully threading the locking bolt through the first component before engaging the second, you will ensure proper seating of the bolt to secure the components together

• This step is repeated to connect the other half of the dual locking connector

• All locking components should be facing away from the extremity to which the frame is applied. This will ensure that you have access to definitively lock all components once the frame is properly positioned

Correct Incorrect

NOTE: Locking connector bolt shouldbe flush against the dual lockingconnector when turningcounterclockwise to remove.

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23

Adding A Dual Locking Connector

• To add a dual locking connector, one locking bolt must be fully removed

• While removing the locking bolts, components should not be held together, but rather should be apart so that threads are only engaged with a single component at a time

• With the locking bolt removed, the frame can be reassembled with the additional dual locking connector

• To reassemble the frame, the locking bolt should be fully threaded through the remaining dual locking connector before it engages the threaded componentof the rotational locking connector or dual locking connector

• By fully threading the locking bolt through the first component before engaging the second, you will ensure proper seating of the bolt to secure the components together

• This step is repeated to connect the other half of the dual locking connector

• All locking components should be facing away from the extremity to which the frame is applied. This will ensure that you have access to definitively lock all components once the frame is properly positioned

Shorter Constructs With (1) Dual Locking Connector Removed

Page 26: Biomet Vision Unilateral Fixator - Hip · Clamp (Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp • All telescoping fixator

Suggested Screw Site Care/Sterilization

At the conclusion of fixator application and fracture

reduction, wounds are dressed in routine sterile fashion.

Care should be taken to ensure all fixator fittings are

securely tightened. Dry sterile gauze is wrapped around

the shanks of the bone screws to prevent pistoning of the

soft tissues on the bone screws. Once wounds have

healed and sutures are removed, routine postoperative

screw site care is recommended. Screw sites should be

monitored during subsequent clinic visits. All fixator

fittings should be evaluated for tightness during

subsequent clinic visits.

The Biomet Vision Unilateral Fixator is provided nonsterile

and must be sterilized prior to use. Repeated sterilization

of carbon fiber reinforced epoxy is not recommended.

All packaging materials must be removed prior to

sterilization. All fixator components should be sterilized

in a loosened state such that components may move

freely. The following steam sterilization parameters

are recommended.

Cycle

Vacuum Steam

Temperature: 270°F/132°C

Time: Eight minutes

NOTE: Allow for cooling

CAUTION: Federal Law (USA) restricts this device to sale

by or on the order of a physician

NOTE: Patents Pending. Made in the USA

WARNING: This device is not approved for screw

attachment or fixation to the posterior elements (pedicles)

of the cervical, thoracic, or lumbar spine. See package

insert for full prescribing information.

24

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25

Product Information

Top Tray

Catalog # Description

20150 Standard Fixator Complete

20380 Ankle Fixator Complete

20390 Variable Ankle Fixator Complete

20300 Arc Clamp

Soft Tissue Guides

03080 40mm Soft Tissue Guide

03085 60mm Soft Tissue Guide

03090 100mm Soft Tissue Guide

Drill Guides

03060 4.8mm Drill Guide

03065 3.2mm Drill Guide

03070 2.9mm Drill Guide

Drill Bits

03020 4.8mm Drill Bit 180mm (Complete)

03010 4.8mm Drill Bit 240mm (Complete)

03225 4.8mm Cannulated Drill Bit w/1.6 P/T

Guide Wire

03040 3.2mm Drill Bit 140mm (Complete)

03030 3.2mm Drill Bit 200mm (Complete)

03050 2.9mm Drill Bit 140mm (Complete)

Instruments

03075 Trocar

03125 T-Wrench for bone screws

21030 L-Torque Wrench (definitive tightening)

21015 Bullet Wrench (provisional tightening)

21020 4mm T-Wrench (provisional tightening)

Additional Components

Catalog # Description

06240 Variable Angle Screw Clamp

14605 MRI SAFE SLM Rapid Rod-to-Screw Clamp

14600 MRI SAFE SLM Rapid Rod-to-Rod Clamp

14160 150mm Carbon Rod

14165 200mm Carbon Rod

14170 250mm Carbon Rod

14175 300mm Carbon Rod

14180 350mm Carbon Rod

14185 400mm Carbon Rod

14650 500mm Carbon Rod

14660 600mm Carbon Rod

02555 4mm Allen Wrench

03110 5mm Allen Wrench

21006 Torque Wrench Replacement Tip

03195 General Surgical Tray

Page 28: Biomet Vision Unilateral Fixator - Hip · Clamp (Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp • All telescoping fixator

Product Information (Continued)

26

6/5 Tapered Cortical Bone Screws With 6mm Shank

Catalog # Thread Type/Thread Length

A60-09030 Cortical - 90/30

A60-09040 Cortical - 90/40

A60-10030 Cortical - 100/30

A60-10040 Cortical - 100/40

A60-11030 Cortical - 110/30

A60-11040 Cortical - 110/40

A60-11050 Cortical - 110/50

A60-12040 Cortical - 120/40

A60-13030 Cortical - 130/30

A60-13040 Cortical - 130/40

A60-13050 Cortical - 130/50

A60-13060 Cortical - 130/60

A60-13070 Cortical - 130/70

A60-14080 Cortical - 140/80

A60-14090 Cortical - 140/90

A60-15030 Cortical - 150/30

A60-15040 Cortical - 150/50

A60-15040T Cortical - 150/40

A60-15050 Cortical - 150/50

A60-15050T Cortical - 150/50

A60-15060 Cortical - 150/60

A60-16030 Cortical - 160/30

A60-16040 Cortical - 160/40

A60-16050 Cortical - 160/50

A60-17040 Cortical - 170/40

A60-17060 Cortical - 170/60

A60-18030 Cortical - 180/30

A60-18040 Cortical - 180/40

A60-18050 Cortical - 180/50

A60-18060 Cortical - 180/60

A60-20050 Cortical - 200/50

A60-20060 Cortical - 200/60

A60-22030T Cortical - 220/30

A60-22040T Cortical - 220/40

A60-22050 Cortical - 220/50

A60-22050T Cortical - 220/50

A60-22060 Cortical - 220/60

A60-22060T Cortical - 220/60

A60-25030T Cortical - 250/30

A60-25040T Cortical - 250/40

A60-25050T Cortical - 250/50

A60-25060T Cortical - 250/60

A60-25080T Cortical - 250/80

A60-25010T Cortical - 250/100

A60-30060 Cortical - 300/60

6/5 Tapered Cancellous Bone Screws With 6mm Shank

Catalog # Thread Type/Thread Length

B60-09030 Cancellous - 90/30

B60-10030 Cancellous - 100/30

B60-10040 Cancellous - 100/40

B60-11040 Cancellous - 110/40

B60-11050 Cancellous - 110/50

B60-12040 Cancellous - 120/40

B60-12060 Cancellous - 120/60

B60-13040 Cancellous - 130/40

B60-13050 Cancellous - 130/50

B60-13060 Cancellous - 130/60

B60-14050 Cancellous - 140/50

B60-15060 Cancellous - 150/60

B60-16070 Cancellous - 160/70

B60-16090 Cancellous - 160/90

B60-17080 Cancellous - 170/80

B60-18090 Cancellous - 180/90

B60-18010 Cancellous - 180/100

B60-20080 Cancellous - 200/80

B60-20090 Cancellous - 200/90

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27

4.5/3.5 Tapered Cortical Bone Screws With 6mm Shank

Catalog # Thread Type/Thread Length

A45-06020 Cortical - 60/20

A45-07020 Cortical - 70/20

A45-08020 Cortical - 80/20

A45-08030 Cortical - 80/30

A45-08040 Cortical - 80/40

A45-10020 Cortical - 100/20

A45-10040 Cortical - 100/40

A45-12020 Cortical - 120/20

A45-12040 Cortical - 120/40

3.5/3.2 Tapered Cortical Bone Screws With 6mm Shank

Catalog # Thread Type/Thread Length

A35-06020 Cortical - 60/20

A35-07020 Cortical - 70/20

A35-08030 Cortical - 80/30

A35-09040 Cortical - 90/40

Self-Drilling, Self-Tapping Bone Screws

Catalog # Thread Type/Thread Length

SD60-15050 Cortical - 150/50

SD60-18060 Cortical - 180/60

SD60-20070 Cortical - 200/70

SD60-25080 Cortical - 250/80

SD50-12030 Cortical - 120/30

SD50-15050 Cortical - 150/50

SD50-18050 Cortical - 180/50

SD50-20080 Cortical - 200/80

SD50-25050 Cortical - 250/50

SD50-25080 Cortical - 250/80

6/5mm Tapered Hydroxyapatite Cortical Bone Screws With

6mm Shank

Catalog # Thread Type/Thread Length

HAA60-11030 Cortical - 110/30

HAA60-11040 Cortical - 110/40

HAA60-11050 Cortical - 110/50

HAA60-12040 Cortical - 120/40

HAA60-13030 Cortical - 130/30

HAA60-13040 Cortical - 130/40

HAA60-13050 Cortical - 130/50

HAA60-15020 Cortical - 150/20

HAA60-15030 Cortical - 150/30

HAA60-15040 Cortical - 150/40

HAA60-15050 Cortical - 150/50

HAA60-15060 Cortical - 150/60

HAA60-16030 Cortical - 160/30

HAA60-18030 Cortical - 180/30

HAA60-18050 Cortical - 180/50

HAA60-18060 Cortical - 180/60

HAA60-20030 Cortical - 200/30

HAA60-20040 Cortical - 200/40

HAA60-20050 Cortical - 200/50

HAA60-20060 Cortical - 200/60

HAA60-20080 Cortical - 200/80

HAA60-22050 Cortical - 220/50

HAA60-22060 Cortical - 220/60

HAA60-25030 Cortical - 250/30

HAA60-25040 Cortical - 250/40

HAA60-25050 Cortical - 250/50

HAA60-25060 Cortical - 250/60

HAA60-30060 Cortical - 300/60

Page 30: Biomet Vision Unilateral Fixator - Hip · Clamp (Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp • All telescoping fixator

Product Information (Continued)

28

6/5mm Tapered Hydroxyapatite Cancellous Bone Screws

With 6mm Shank

Catalog # Thread Type/Thread Length

HAB60-10030 Cancellous - 100/30

HAB60-11040 Cancellous - 110/40

HAB60-11050 Cancellous - 110/50

HAB60-12040 Cancellous - 120/40

HAB60-12060 Cancellous - 120/60

HAB60-13040 Cancellous - 130/40

HAB60-13060 Cancellous - 130/60

HAB60-14050 Cancellous - 140/50

HAB60-15060 Cancellous - 150/60

HAB60-16070 Cancellous - 160/70

HAB60-16090 Cancellous - 160/90

HAB60-17080 Cancellous - 170/80

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29

Further Information

This brochure describes the surgical technique used by

James V. Nepola, M.D. Biomet Trauma, as the manufacturer

of this device, does not practice medicine and does not

recommend this product or any surgical technique for use

on any individual patient. The surgeon who performs any

implant procedure is responsible for determining the

appropriate product(s) and utilizing the appropriate

technique(s) for said implantation in each individual patient.

For further information, please contact the Customer

Service Department at:

Biomet Trauma

100 Interpace Parkway

Parsippany, NJ 07054

(973) 299-9300 - (800) 526-2579

www.biomettrauma.com

Page 32: Biomet Vision Unilateral Fixator - Hip · Clamp (Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp • All telescoping fixator

30

Notes:

Page 33: Biomet Vision Unilateral Fixator - Hip · Clamp (Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp • All telescoping fixator

31

Notes:

Page 34: Biomet Vision Unilateral Fixator - Hip · Clamp (Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp • All telescoping fixator

32

Notes:

Page 35: Biomet Vision Unilateral Fixator - Hip · Clamp (Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp • All telescoping fixator
Page 36: Biomet Vision Unilateral Fixator - Hip · Clamp (Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp • All telescoping fixator

Copyright 2007 Biomet, Inc. All rights reserved. P/N 192315L 02/07

For full prescribing information, contact Biomet Trauma, a subsidiary of Biomet, Inc. Unless otherwiseindicated, ™ denotes a trademark, and ® denotes a registered trademark, of one of the followingcompanies: Biomet, Inc.; Electro-Biology, Inc.; EBI, L.P.; Biolectron, Inc.; EBI Medical Inc.; InterporeCross International, Inc.; Cross Medical Products; or Interpore Orthopaedics, Inc.

100 Interpace ParkwayParsippany, NJ 07054www.biomettrauma.com800-526-2579