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Tactys Operative Technique - Stryker

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Hand &<br />

Wrist<br />

TACTYS<br />

Proximal Interphalangeal<br />

Joint Prosthesis<br />

<strong>Operative</strong> <strong>Technique</strong><br />

Hand & Wrist


TACTYS<br />

This publication sets forth detailed<br />

recommended procedures for using<br />

<strong>Stryker</strong> Osteosynthesis devices and<br />

instruments.<br />

It offers guidance that you should<br />

heed, but, as with any such technical<br />

guide, each surgeon must consider<br />

the particular needs of each patient<br />

and make appropriate adjustments<br />

when and as required.<br />

A workshop training is recommended<br />

prior to first surgery.<br />

All non-sterile devices must be<br />

cleaned and sterilized before use.<br />

Follow the appropriate instructions<br />

for use (IFU). Multi-component<br />

instruments must be disassembled<br />

for cleaning. Please refer to the<br />

corresponding assembly/disassembly<br />

instructions.<br />

See package insert for a complete<br />

list of potential adverse effects,<br />

contraindications, warnings and<br />

precautions.<br />

The surgeon must discuss all relevant<br />

risks, including the finite lifetime of<br />

the device, with the patient, when<br />

necessary.<br />

2


Contents<br />

Page<br />

1. Indications and Contraindications 4<br />

Indications 4<br />

Contraindications 4<br />

Concept 4<br />

Precautions 4<br />

2. Characteristics 5<br />

3. <strong>Operative</strong> <strong>Technique</strong> 6<br />

Approaches 6<br />

Resection of proximal and distal articular surfaces 8<br />

Preparation of the Proximal Phalanx 10<br />

Preparation of the Distal Phalanx 12<br />

Fitting the trial stem 14<br />

Positioning of the trial articulating surfaces 16<br />

Fitting the final implants 18<br />

Closure of the extensor apparatus 19<br />

Ordering Information – Implants 21<br />

Ordering Information – Instruments 22<br />

3


Indications, Precautions & Contraindications<br />

Indications<br />

The <strong>Tactys</strong> prosthesis is intended for<br />

use in hand proximal interphalangeal<br />

joint arthroplasty associated with<br />

osteoarthritis, rheumatoid arthritis,<br />

trauma (fracture) and revision surgery.<br />

Concept<br />

The innovative four-part prosthesis<br />

simulates the physiological movement<br />

of the joint while limiting bone<br />

resection. The design is modular to<br />

suit different morphologies and to<br />

enable intraoperative tensioning of<br />

the joint.<br />

Precautions<br />

<strong>Stryker</strong> Osteosynthesis systems have<br />

not been evaluated for safety and<br />

compatibility in MR environment<br />

and have not been tested for heating<br />

or migration in the MR environment,<br />

unless specified otherwise in the product<br />

labeling or respective operative<br />

technique. Detailed information is<br />

included in the instructions for use<br />

being attached to every implant.<br />

Contraindications<br />

• Acute or chronic infections, local<br />

or systemic.<br />

• Muscular, neurological or vascular<br />

severe deficiency affecting the<br />

articulation.<br />

• Osseous demineralization or<br />

destruction being able to affect the<br />

implant fixing.<br />

• The association of this implant with<br />

implants having another origin is not<br />

agreed.<br />

• Surgical procedures others that those<br />

mentioned in the INDICATIONS<br />

section.<br />

• Do not use on patients who are<br />

allergic to the product’s components<br />

or who have known allergies.<br />

More than 400 configurations at your disposal<br />

4


Characteristics<br />

Proximal articulating surface made of<br />

polymer that can easily be replaced in<br />

the event of revision.<br />

Proximal<br />

Articulating Surface<br />

Ultra-High Molecular<br />

Weight Polyethylene<br />

Distal Articulating Surface<br />

Cobalt-Chromium Alloy<br />

Distal Stem<br />

Titanium Alloy<br />

Half Hydroxyapetite<br />

coating<br />

Press-fit Anatomical<br />

Design<br />

Half Hydroxyapatite<br />

coating<br />

Proximal stem<br />

Titanium Alloy<br />

Press-fit<br />

Anatomical Design<br />

Abutment to<br />

prevent stem<br />

from sinking into<br />

phalanx<br />

Instrumentation<br />

• Ergonomic instrumentation specific<br />

to each phalange.<br />

• Colour-coding for each instrument<br />

and the box<br />

Orange: Distal<br />

Black: Proximal<br />

Proximal<br />

Instrumentation<br />

Trial Implants<br />

Distal<br />

Instrumentation<br />

Identification of XS, S, M, L trial<br />

implants by specific colour code<br />

L<br />

M<br />

S<br />

XS<br />

5


<strong>Operative</strong> <strong>Technique</strong><br />

Approaches<br />

The dorsal approach, thanks to its wide unimpeded access, is particularly<br />

recommended for implanting the <strong>Tactys</strong> prosthesis. However, the choice<br />

of approach is at the surgeon’s discretion according to his experience and training.<br />

Dorsal trans tendinous approach*<br />

Perform a curvilinear skin incision 3<br />

to 4cm along the back of the PIP joint.<br />

3 - 4cm<br />

Perform a median longitudinal<br />

incision into the extensor apparatus<br />

moving to the centre of the insertion<br />

of the central slip and continuing with<br />

the dorsal periosteum of P2.<br />

The incision begins in the middle<br />

of the proximal phalanx and runs<br />

through the centre of the middle<br />

phalanx.<br />

3 - 4cm<br />

Separate the two flaps of the extensor<br />

apparatus, one to radial and the other<br />

to ulnar in order to expose the joint.<br />

It is not necessary to detach the<br />

periosteum.<br />

* Source: Scientific literature on pg 20<br />

6


<strong>Operative</strong> <strong>Technique</strong><br />

Approaches<br />

Chamay-type approach*<br />

The skin approach is curvilinear or<br />

linear dorsal. The incision starts at<br />

the base of P1 and ends at the base<br />

of P2.<br />

3 - 4cm<br />

Proceed with the incision of the<br />

extensor apparatus. The incision starts<br />

from the distal base of P2, at the union<br />

of the lateral slips and of the central<br />

slip and ends in a V or U-shape at the<br />

proximal metaphysis of P1.<br />

Note:<br />

Take care not to incise the<br />

periosteum. It must remain<br />

intact to prevent adhesions<br />

with the tendon.<br />

Lift back the V or U-shape flap of the<br />

extensor. If necessary, proceed with<br />

a resection, exercising caution with<br />

respect to the distal osteophyte.<br />

* Source: Scientific literature on pg 20<br />

7


<strong>Operative</strong> <strong>Technique</strong><br />

Resection of proximal and distal articular surfaces<br />

Resection of the proximal articular<br />

surface (P1)<br />

Resection of the condyle is performed<br />

very close to the proximal insertion<br />

of the lateral ligaments using the<br />

oscillating saw while remaining<br />

perpendicular in both planes to<br />

the axis of the phalanx.<br />

Resect the dorsal osteophytes<br />

if necessary.<br />

Note:<br />

Flex the joint to its maximum<br />

extent. The cut through the<br />

condyle must pass very close<br />

to the lateral ligaments.<br />

Resection of the distal articular<br />

surface (P2)<br />

Perform a minimal resection of the<br />

articular surface of the 2nd phalanx<br />

with the aim of obtaining a flat surface<br />

perpendicular to the two planes and<br />

to the axis of the phalanx. Take care to<br />

give consideration to the insertion of<br />

the lateral ligaments.<br />

The resection is performed using an<br />

oscillating saw or using a burr, a gouge<br />

forceps or bone-cutting forceps.<br />

Note:<br />

The Chamay approach does<br />

not always permit the use of an<br />

oscillating saw for the preparation<br />

of P2. A truncated conical burr<br />

(maximum 5mm diameter) can<br />

be used instead. Be aware of the<br />

central slip when completing the<br />

resection.<br />

Reposition the two phalanges<br />

one facing the other to check the<br />

orthogonality of the cuts relative to<br />

the axis of the finger.<br />

8


<strong>Operative</strong> <strong>Technique</strong><br />

Checking the thicknesses of cuts<br />

The sizing control gauge<br />

(Ref XDI008001) allows you to both:<br />

1. Identify the anatomical dimensions<br />

of the surfaces and thus identify the<br />

most suitable L, M or S implant for<br />

the proximal and distal surface.<br />

Note:<br />

Make a note of the size of the<br />

articular surface previously<br />

selected in order to select the<br />

sizing pin for insertion.<br />

The prothesis is modular. The choice of the sizes of the articular surfaces can be<br />

changed intra-operatively.<br />

2. Measure the gap between the<br />

two phalanges to check whether<br />

the bone resection is sufficient to<br />

accommodate at least one distal<br />

articular surface of thickness “L-,<br />

M- or S-”<br />

If the pin can be inserted into the joint<br />

space then the bone resection<br />

is sufficient.<br />

If the pin does not fit, then the bone<br />

resections need to be adjusted to<br />

achieve a sufficiently large gap adapted<br />

to the selected size (S-, L-, M-).<br />

9


<strong>Operative</strong> <strong>Technique</strong><br />

Preparation of the Proximal Phalanx<br />

Proximal seat<br />

Use of the pre-drilling punch<br />

The punch (Ref XDI006001) has an<br />

anatomical design shaped like the<br />

articular surface. The punch enables<br />

the identification of the drilling<br />

position in the medullary canal.<br />

Position Check<br />

Insertion of the 1.5 diameter wire<br />

(Provided in the <strong>Tactys</strong> instrument<br />

set.)<br />

Take a frontal and lateral X-Ray.<br />

Radiographic criteria:<br />

Positioning must be perfectly<br />

intramedullary and into the axis<br />

of the phalanx in both planes.<br />

Seat Preparation<br />

Fitting a S, M, L Stem<br />

Start the preparation of the housing<br />

using the proximal cannulated rasp<br />

(Ref XRP005001) until it abuts the<br />

proximal surface.<br />

10


<strong>Operative</strong> <strong>Technique</strong><br />

Note:<br />

If very hard bone is encountered,<br />

it may be necessary to alternate<br />

between using the cannulated<br />

rasp and the intramedullary<br />

reamer (Ref XFR003001;<br />

Maximum speed limit of the<br />

centromedullar reamer: 100<br />

000 min- 1 ) or guide wire (Ref<br />

XVIPR02001) in order to<br />

successfully create the housing.<br />

It is advisable to take an X-Ray<br />

to check the progress of the rasp.<br />

Fitting an XS stem<br />

For an XS-sized stem (usually the 5th<br />

digital ray) the housing is prepared<br />

directly using the XS proximal rasp<br />

(Ref XRP006001).<br />

Withdraw the wire, then rasp using<br />

the proximal progressive rasp<br />

(Ref XRP007001) until successfully<br />

obtaining a properly adapted seat.<br />

11


<strong>Operative</strong> <strong>Technique</strong><br />

Use the graduated markings on<br />

the measuring tool (Ref XDI007001)<br />

to assess which stem to select.<br />

Note:<br />

As the prosthesis is fully modular,<br />

the articular surface selected<br />

is compatible with any stem<br />

S, M or L.<br />

Preparation of the Distal Phalanx<br />

Distal seat<br />

Using the pre-drilling punch<br />

The punch (Ref XDI006002) has an<br />

anatomical design shaped like the<br />

articular surface. The punch enables<br />

the identification of the drilling<br />

position in the medullary canal.<br />

Position Check<br />

Insert a 1.5mm diameter wire and take<br />

a frontal and lateral X-Ray to check<br />

that it is correclty positioned.<br />

Radiographic criteria:<br />

Positioning must be perfectly<br />

intramedullary and into the axis<br />

of the phalanx in both planes.<br />

12


<strong>Operative</strong> <strong>Technique</strong><br />

Seat Preparation<br />

Fitting a stem S, M or L<br />

Start to prepare the seat by using<br />

the distal cannulated rasp<br />

(Ref XRP005002).<br />

Note:<br />

If very hard bone is encountered,<br />

it may be necessary to alternate<br />

between using the cannulated<br />

rasp and the intramedullary<br />

reamer (Ref XFR003001;<br />

Maximum speed limit of the<br />

centromedullar reamer: 100<br />

000 min- 1 ) or guide wire (Ref<br />

XVIPR02001) in order to<br />

successfully create the housing.<br />

It is advisable to take an X-Ray to<br />

check the progress of the rasp.<br />

Fitting an XS stem<br />

In the case of an XS-sized stem<br />

(5th digital ray mainly) the seat<br />

is prepared directly using the<br />

“XS distal rasp”.<br />

Withdraw the wire, then rasp using<br />

the distal progressive rasp (Ref<br />

XRP007002), until successfully<br />

obtaining a properly adapted seat.<br />

13


<strong>Operative</strong> <strong>Technique</strong><br />

Use the graduated markings on the<br />

measuring tool (Ref XDI007002)<br />

to assess which stem to select.<br />

Note:<br />

The prosthesis is modular.<br />

The distal stem is neither<br />

dependent on the predetermined<br />

size using the checking tool,<br />

nor on the proximal stem implant<br />

that was originally identified as<br />

being suitable.<br />

Fitting the trial stem<br />

Fitting the proximal trial stem<br />

Fit the stem into the seat then proceed<br />

with impaction using the proximal<br />

impactor (Ref XIM007001).<br />

14


<strong>Operative</strong> <strong>Technique</strong><br />

Fitting the distal trial stem<br />

Impaction is performed using the<br />

distal impactor (Ref XIM007002).<br />

Palmar proximal resection<br />

using the cutting guide<br />

The guide (Ref XVIPR001001)<br />

is positioned to rest against the dorsal<br />

stop of the proximal trial stem.<br />

The pin of the guide is inserted<br />

into the housing of the trial stem.<br />

Use an oscillating saw to complete the<br />

palmar resection<br />

Note:<br />

The use of a narrow saw is<br />

recommended so as to minimise<br />

the risk of damage to the lateral<br />

ligaments.<br />

Dorsal cortex removal<br />

Take care to free the dorsal cortex<br />

of P1 (1), using a saw or a gouge<br />

forceps, so as to eliminate residual<br />

bone debris. If this is necessary, use<br />

the saw to remove final bone debris<br />

from the palmar resection (2).<br />

Note:<br />

The presence of bone debris at the<br />

periphery of the stem may impair<br />

the impactaction of the final<br />

surface and its retention on the<br />

stem.<br />

15


<strong>Operative</strong> <strong>Technique</strong><br />

Positioning of the trial articulating surfaces<br />

Fitting the articulating<br />

trial surfaces<br />

Choose articulating surface implants<br />

taking into account the anatomical<br />

dimensions of the condyle and the gap<br />

previously identified using the sizing<br />

control tool (step 2, page 9). Ensure<br />

that the selected surfaces match the<br />

patient’s anatomy as closely as possible.<br />

Start by positioning a proximal trial<br />

surface, then select a distal trial surface<br />

within the smallest thickness range<br />

(S-, M- or L-).<br />

Note:<br />

When fitting the proximal<br />

surface, it is necessary to<br />

thoroughly check that the<br />

proximal surface is in positive<br />

contact with the trial stem. If not,<br />

cleaning of the stem periphery<br />

(page 15) must be repeated.<br />

Articular tension and<br />

check adjustment<br />

It is possible to adjust articular tension<br />

by inserting a distal surface of a greater<br />

or lesser thickness.<br />

Complete several tests to determine<br />

the best performing combination.<br />

Note:<br />

With a transtendinous approach,<br />

the correctness of the articular<br />

tension can be assessed by the<br />

effect of tenodesis. During<br />

flexion-extension of the wrist,<br />

the tenodesis effect of the extensor<br />

apparatus must allow full flexion<br />

and extension of the PIP.<br />

Implants, stems and surfaces are interchangeable.<br />

16


<strong>Operative</strong> <strong>Technique</strong><br />

Osteophyte check<br />

Take frontal and lateral X-Rays<br />

of the trial implants. Check that<br />

no osteophyte is impairing the<br />

positioning of the implants<br />

Removal of the trial implants<br />

Remove the articulating surfaces using<br />

the forceps (Ref XPI009001) and then<br />

the stems using the removal forceps<br />

(Ref XPI009002).<br />

17


<strong>Operative</strong> <strong>Technique</strong><br />

Fitting the final<br />

implants<br />

Preparation of the extensor<br />

apparatus in the case of<br />

a transtendinous approach and<br />

reinsertion* of the central slip.<br />

Before fitting the final stems, make<br />

two holes on the dorsal face of the<br />

median phalanx for reinsertion of the<br />

extensor apparatus.<br />

Note:<br />

Reinsertion of the central slip is at<br />

the surgeons discretion.<br />

A reinsertion with excessive<br />

tension may cause postoperative<br />

stiffness.<br />

Fitting the final implants<br />

The procedure for fitting the final<br />

implants is exactly the same as the<br />

procedure for fitting the trial implants.<br />

Impaction of the articulating surfaces<br />

is completed using distal and proximal<br />

articulating surface impactors.<br />

1. Insertion of the proximal stem.<br />

2. Inserting the distal stem.<br />

3. Impaction of the proximal surface.<br />

4. Impaction of the distal surface.<br />

Note:<br />

Be sure to follow the correct<br />

order for fitting components. It is<br />

preferable to impact the proximal<br />

surface before the distal surface.<br />

* Source: Scientific literature on pg 20<br />

18


<strong>Operative</strong> <strong>Technique</strong><br />

X-Ray check<br />

Check that the final implants are<br />

properly positioned using frontal<br />

and lateral X-Rays.<br />

Closure of the<br />

extensor apparatus<br />

Dorsal transtendinous approach*<br />

Reinsert the strip of the extensor<br />

apparatus (Fig.1) without excessive<br />

tension of the latter at the base of P2<br />

using two transosseous holes.<br />

Fig.2 shows reinsertion of the extensor<br />

apparatus without reinsertion of the<br />

central slip.<br />

Fig.1<br />

Fig.2<br />

Chamay approach*<br />

Once the prosthesis is fitted, suture<br />

the extensor using a fairly fine thread<br />

by means of individual, separate<br />

points. 20 to 25 points are generally<br />

required.<br />

After closing up the cutaneous flap,<br />

the finger is bandaged and strapped<br />

to the adjoining digit for immediate<br />

mobilization of the phalanges.<br />

Note:<br />

It is important not to hold the<br />

joint in strict extension.<br />

Chamay approach<br />

* Source: Scientific literature on pg 20<br />

19


Proposed postoperative care protocol<br />

The protocol must be tailored to each patient<br />

The following is recommended:<br />

• Strap the finger to the adjoining digit for 15 days and avoid any compressive<br />

dressing<br />

• Prevent any strict, prolonged immobilization in extension<br />

• Prevent any hyperextension<br />

• Focus on immediate rehabilitation in flexion<br />

• Elevate the hand<br />

A 15-day check-up will allow you to assess the degree of mobility of the joint,<br />

to prevent any eventual complications. An X-Ray in full flexion is recommended.<br />

* Scientific Literature: Transtendinous dorsal approach, Chamay approach<br />

Afifi, A. M., A. Richards, et al. (2010). “The extensor tendon splitting approach<br />

to the proximal interphalangeal joint: do we need to reinsert the central slip?” J<br />

Hand Surg Eur Vol 35(3): 188-91.<br />

Bickel, K. D. (2007). “The Dorsal Approach to Silicone Implant Arthroplasty of<br />

the Proximal Interphalangeal Joint.” The Journal of Hand Surgery 32(6): 909-913.<br />

Chamay, A. (1988). “Le lambeau tendineux triangulaire dorsal inversé, porte<br />

ouverte sur l’articulation interphalangienne proximale (IPP).” Annales de<br />

Chirurgie de la Main 7(2): 179-183.<br />

Mercer, D., J. FitzPatrick, et al. (2009). “Extensor Tendon Repair With and<br />

Without Central Slip Reattachment to Bone: A Biomechanical Study.” The Journal<br />

of Hand Surgery 34(1): 108-111.<br />

20


Ordering Information – Implants<br />

REF<br />

Description<br />

WIPSP11<br />

Proximal surface size L<br />

WIPSP10<br />

Proximal surface size M<br />

WIPSP07<br />

Proximal surface size S<br />

WIPTP18<br />

Proximal stem size L<br />

WIPTP16<br />

Proximal stem size M<br />

WIPTP14<br />

Proximal stem size S<br />

WIPTP12<br />

Proximal stem size XS<br />

WIPSD1205 Distal surface size L-<br />

WIPSD1210<br />

Distal surface size L0<br />

WIPSD1215 Distal surface size L+<br />

WIPSD1005 Distal surface size M-<br />

WIPSD1010<br />

Distal surface size M0<br />

WIPSD1015 Distal surface size M+<br />

WIPSD0705 Distal surface size S-<br />

WIPSD0710<br />

Distal surface size S0<br />

WIPSD0715 Distal surface size S+<br />

WIPTD15<br />

Distal stem size L<br />

WIPTD13<br />

Distal stem size M<br />

WIPTD11<br />

Distal stem size S<br />

WIPTD09<br />

Distal stem size XS<br />

21


Ordering Information – Instruments<br />

REF<br />

Description<br />

XDI006001<br />

Proximal punch<br />

XDI006002<br />

Distal punch<br />

XRP005001<br />

Proximal canulated rasp<br />

XRP005002<br />

Distal canulated rasp<br />

XRP007001<br />

Progressive proximal rasp<br />

XRP007002<br />

Progressive distal Rasp<br />

XRP006001<br />

Proximal XS rasp<br />

XRP006002<br />

Distal XS rasp<br />

XDI007001<br />

Proximal stem measuring tool<br />

XDI007002<br />

Distal stem measuring tool<br />

XIM007001<br />

Proximal stem impactor<br />

XIM007002<br />

Distal stem impactor<br />

XIM007003<br />

Proximal surface impactor<br />

XIM007004<br />

Distal surface impactor<br />

XVIPR001001<br />

Palmar cutting guide<br />

XPI009001<br />

Surface forceps<br />

XPI009002<br />

Stem forceps<br />

AGK0215100<br />

Kirchner wire<br />

XTU001001<br />

Wire tube<br />

XDI008001<br />

Size Control Gauge<br />

XFR003001<br />

Centromedullary reamer<br />

XVIPR02001<br />

Guide Wire<br />

22


Ordering Information – Trials<br />

REF<br />

Description<br />

XFA010110<br />

Proximal surface trial size L<br />

XFA010120<br />

Proximal surface trial size M<br />

XFA010130<br />

Proximal surface trial size S<br />

XFA009110<br />

Proximal stem trial size L<br />

XFA009120<br />

Proximal stem trial size M<br />

XFA009130<br />

Proximal stem trial size S<br />

XFA009140<br />

Proximal stem trial size XS<br />

XFA010210 Distal surface trial size L-<br />

XFA010211<br />

Distal surface trial size L0<br />

XFA010212 Distal surface trial size L+<br />

XFA010220 Distal surface trial size M-<br />

XFA010221<br />

Distal surface trial size M0<br />

XFA010222 Distal surface trial size M+<br />

XFA010230 Distal surface trial size S-<br />

XFA010231<br />

Distal surface trial size S0<br />

XFA010232 Distal surface trial size S+<br />

XFA009210<br />

Distal stem trial size L<br />

XFA009220<br />

Distal stem trial size M<br />

XFA009230<br />

Distal stem trial size S<br />

XFA009240<br />

Distal stem trial size XS<br />

23


Notes<br />

24


Notes<br />

25


1275 0120<br />

This document is intended solely for the use of healthcare professionals. A surgeon must always rely on his or her own<br />

professional clinical judgment when deciding whether to use a particular product when treating a particular patient.<br />

<strong>Stryker</strong> does not 1275<br />

dispense medical advice and recommends that surgeons be trained in the use of any particular<br />

product before using it in surgery.<br />

Manufactured by:<br />

Memometal Technologies SA<br />

Campus de Ker Lann<br />

Rue Blaise Pascal<br />

35170 Bruz<br />

France<br />

www.stryker.com<br />

The information presented is intended to demonstrate a <strong>Stryker</strong> product. A surgeon must always refer to the package<br />

insert, product label and/or instructions for use, including the instructions for Cleaning and Sterilization (if<br />

applicable), before using any <strong>Stryker</strong> product. Products may not be available in all markets because product availability<br />

is subject to the regulatory and/or medical practices in individual markets. Please contact your <strong>Stryker</strong> representative<br />

if you have questions about the availability of <strong>Stryker</strong> products in your area.<br />

<strong>Stryker</strong> Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following<br />

trademarks or service marks: <strong>Tactys</strong>, <strong>Stryker</strong>. All other trademarks are trademarks of their respective owners or<br />

holders.<br />

The products listed above are CE marked.<br />

Literature Number : 982384 Rev 0<br />

Copyright © 2012 <strong>Stryker</strong>

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