biomet vision unilateral fixator surgical technique...additional indications for the biomet® vision...
TRANSCRIPT
Surgical Technique
Biomet® Vision™ Unilateral Fixator
Contents
Introduction .................................................... Page 1
Design Features.............................................. Page 7
Instruments .................................................... Page 8
Standard Fixator Technique ............................ Page 9
Arc Clamp With Standard ................................ Page 15
Fixator Technique
Ankle Fixator And Variable Ankle .................... Page 16
Fixator Technique
System Assembly/Disassembly ...................... Page 22
Suggested Screw Site Care/Sterilization ......... Page 24
Product Information ........................................ Page 25
Further Information ......................................... Page 29
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.
INDICATIONS
The DynaFix Vision Unilateral System and the DynaFix Vision
External Fixation System are external fixation device intended
for use in the treatment of bone conditions including leg
lengthening, osteotomies, arthrodesis, fracture fixation, and other
bone conditions amenable to treatment by use of the external
fixation modality.
Additional indications for the Biomet® Vision FootRing System,
a sub system of the DynaFix Vision External Fixation System
include:
• Correction of deformity
• Revision procedures where other treatments or devices
have been unsuccessful
• Bone reconstruction procedures
• Fusions and replantations of the foot
• Charcot reconstruction and Lisfranc dislocations
• Ankle distraction (arthrodiastasis)
CONTRAINDICATIONS
Patients with mental or neurologic conditions who are unwilling
or incapable of following postoperative care instructions.
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 Clamp with CD Mechanism (1 each)
Rotational Locking Connectors(2 each)
Locking Connector Bolt (3 each)
Dual Locking Connector (2 each)
Fixed Clamp (1 each)
2
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 Clamp with CD Mechanism (1 each)
Rotational Locking Connectors(2 each)
Variable Ankle Fixator complete offers a variable position talar pin clamp that provides increased flexibility when applying the ankle fixator to the patient.
Locking Connector Bolt (3 each)
Dual Locking Connector (2 each)
Ankle Clamp
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 page 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 Clamp with 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
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 the rotational
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 locking
connector 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 articulation from
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
Locking Setscrew
Clamp Cover Locking Bolts(2 each)
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 and straight 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 to the
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 clamp
and the remaining locking setscrew secures the straight clamp to the rotational locking connector
• Telescoping fixator clamp cover can be removed for application of MRI Safe SLM Rapid Rod-to-Screw Clamp
(Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp
• All telescoping fixator clamp locking components are definitively secured using a torque wrench
CD Mechanism
Telescoping Fixator Clamp Cover
Locking Setscrews (4 each)
Clamp Cover Locking Bolts (2 each)
Straight Clamp
Distraction limit
Catalog #14605
Total length = 4.5cm
Straight Clamp shown with telescoping fixator clamp cover removed
Each line = 2mm
6
7
Design Features
• Carbon fiber components are radiolucent, strong and lightweight
• Unique central body design permits controlled fracture reduction in any plane
• System is completely modular, allowing for a variety of frame configurations that address periarticular and diaphyseal applications
• Serrated locking connectors provide a mechanical locking mechanism with up to 120° of articulation in any plane
• Universal Application - Ability for fixator to be used on either the right or left side of body
• New Telescoping Fixator Clamp cover can be removed for application of Biomet Vision Pin-to-Bar to Straight Clamp
• New Variable Ankle Fixator complete offers a variable position talar pin clamp that provides increased flexibility when applying the ankle fixator to the patient
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
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
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
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
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)
NOTe: Ensure at least 1cm of space is between telescoping cover and straight clamp.
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 (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 14)
Figure 14
Figure 13
NOTe: Ensure at least 3cm clearance between fixator body and skin surface.
Figure 11
Figure 12
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 (or compression) is desired, the proximal locking setscrew must first be definitively tightened with a torque wrench.
NOTe: If distraction (or compression) is desired, ensure the two distal locking setscrews are NOT definitively tightened. Upon desired distraction, lock the setscrews with a torque wrench.
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
Standard Fixator Technique (Continued)
14
Standard Fixator shown with Straight Clamp and SLM Rapid
Rod-to-Screw Clamps (Catalog #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.
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 (Catalog #14605) applied.
NOTe: CD Mechanism cannot be used for this construct.
Figure 20
Alternatively, a Variable Angle Screw Clamp can be affixed to bone screw.
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 page 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
NOTe: Clamp Cover Locking Bolts must face distal
Figure 21 Figure 22
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 25
Figure 26
Figure 24
Male Female
NOTe: Bone screws shown inserted
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 locking setscrew must first be definitively tightened with a torque wrench.
NOTe: If distraction (or compression) is desired, ensure the two distal locking setscrews are NOT definitively tightened. Upon desired distraction, lock the setscrews with a torque wrench.
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
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: (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.
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.
Figure 30
Figure 31
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.
21
Variable Ankle Fixator shown with MRI SAFE SLM
Rapid Rod-to-Screw Clamps (Catalog #14605) and MRI SAFE SLM
Rapid Rod-to-Rod Clamp (Catalog #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 (Catalog #14605) applied.
NOTe: CD Mechanism cannot be used for this construct.
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 threads are 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 should be flush against the dual locking connector when turning counterclockwise to remove.
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 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
Shorter Constructs With (1) Dual Locking Connector Removed
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
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
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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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
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
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
56 East Bell Drive
P.O. Box 587
Warsaw, Indiana 46581-0587
800.348.9500 x 1501
www.biomet.com
30
Notes:
31
Notes:
32
Notes:
©2013 Biomet Orthopedics • Form No. BMET0349.0 • REV011513
All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless otherwise indicated.
This material is intended for the sole use and benefit of the Biomet sales force and health care professionals. It is not to be redistributed, duplicated or disclosed without the express written consent of Biomet.
For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert and Biomet’s website.
Responsible ManufacturerBiomet, Inc. P.O. Box 58756 E. Bell DriveWarsaw, Indiana 46581-0587 USA
www.biomet.com
Rx only.