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Staple Fixation System - Stryker

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<strong>Staple</strong> <strong>Fixation</strong><br />

<strong>System</strong><br />

• Implants<br />

• Instruments<br />

• Applications


Contents<br />

Introduction 3<br />

Instrument Use - Universal Inserter 4<br />

Instrument Use - Universal Rod 5<br />

Ordering Information - Implants 6<br />

Ordering Information - Instruments 7<br />

2


Introduction<br />

When the stapling of bones, ligaments,<br />

tendons or soft tissue is part of an<br />

operative procedure, then the new<br />

advanced <strong>Staple</strong> Instrumentation<br />

<strong>System</strong> combined with a complete<br />

family of <strong>Fixation</strong> <strong>Staple</strong>s offers<br />

clear-cut advantages.<br />

Implants<br />

Instruments<br />

The <strong>Stryker</strong> <strong>Staple</strong> <strong>System</strong> consists of<br />

eight different <strong>Staple</strong> designs. They<br />

differ in their function and indication.<br />

The Ellison Arched Bridge <strong>Staple</strong>s are<br />

designed to reduce the risk of the<br />

staple backing out of the bone and to<br />

reattaching tubular soft tissue to bone.<br />

The Ellison Flat <strong>Staple</strong>s are used to<br />

attach bone to bone.<br />

The Ellison removable Soft Tissue<br />

Retainer can be used with the flat<br />

<strong>Staple</strong> for soft tissue reattachment.<br />

All Ellison <strong>Staple</strong>s are barbed on all<br />

four sides of the legs for enhanced<br />

fixation and protection against back<br />

out.<br />

Depalma <strong>Staple</strong> – same indication as<br />

the Ellison Arched Bridge <strong>Staple</strong> but<br />

without barbed legs.<br />

The Blount Epiphyseal <strong>Staple</strong>s are<br />

applicable for epiphyseal applications<br />

in children and adolescents. The<br />

reinforced corners reduce unwanted<br />

staple bending and allow accurate<br />

staple driving.<br />

Stepped <strong>Staple</strong>s provide the most<br />

comprehensive approach to bone<br />

fixation following high tibial<br />

osteotomies. These staples are available<br />

in three offset steps (5, 10 and 15mm)<br />

The Kremser <strong>Staple</strong> for HTO can be<br />

locked with a standard 4.5mm self<br />

tapping cortical screw through a<br />

special locking hole in the distal leg.<br />

Fracture <strong>Staple</strong>s have slightly tapered<br />

legs. This feature creates compression<br />

when the staples are driven in bone.<br />

Wire <strong>Staple</strong>s are indicated for fragment<br />

fixation, particularly in small<br />

fragments and where inter-fragmental<br />

screw fixation is not possible.<br />

All staples are manufactured from<br />

Vitallium alloy, fully conforming to the<br />

requirements set by ASTM F799/ISO<br />

5832 standards.<br />

The upgraded instrumentation system<br />

features a unique universal staple<br />

inserter for accurate staple impaction<br />

into bone. The special<br />

holding/tightening mechanism enables<br />

secure gripping of the staples and<br />

allows easy exchange of the three<br />

different clamping jaws.<br />

The system also includes a universal<br />

rod to connect the final impactor,<br />

extraction spoon and a extraction hook<br />

together with a slotted hammer. A<br />

swivel drill guide for pre-drilling<br />

cortical bone is available as an optional<br />

item. All instruments are stored in a<br />

plastic sterilization case together with a<br />

tray for staples. The tray with preformed<br />

inserts holds a variety of<br />

<strong>Staple</strong>s for easy intra-operative<br />

selection.<br />

3


Instrument Use<br />

Universal Inserter<br />

Assembling the Inserter<br />

Three different clamping jaws are<br />

available for insertion of the staple<br />

range. If the jaws need changing the<br />

following procedure must be followed:<br />

Turn the knob anti-clockwise until it<br />

disengages from the threaded shaft.<br />

Remove the spring and push the shaft<br />

forward through the instrument<br />

casing.<br />

Select the appropriate clamping jaws<br />

and place the two parts on the distal<br />

end of the shaft using the transverse<br />

pegs. Firmly press the jaws on the shaft<br />

and re-insert the shaft through the<br />

casing.<br />

Ensure that the two pegs engage in the<br />

longitudinal slots in the casing. Keep<br />

the clamping jaws pressed against the<br />

conical end of the casing. Slide the<br />

spring over the threaded end of the<br />

shaft and reattach the knob to the<br />

thread.<br />

Turn the knob clockwise and advance<br />

until a gap of approx. 5mm to the<br />

proximal end of the casing has been<br />

reached.<br />

Using the inserter<br />

Spread the clamping jaws by pushing<br />

the knob against the casing and insert<br />

the selected staple correctly in the<br />

chosen clamping jaws.<br />

Release the pressure on the knob so<br />

that the spring-loaded mechanism<br />

keeps the staple fixed in the jaws.<br />

Tighten the knob until firm resistance<br />

can be felt, confirming secure fixation<br />

of the staple in the clamping jaws.<br />

After impaction of the staple into the<br />

bone, turn the knob anti-clockwise<br />

several turns and release the<br />

instrument by pushing the knob<br />

against the casing.<br />

4


Instrument Use<br />

Universal Rod<br />

The Universal Rod has been designed<br />

for the use with the Final Impactor, the<br />

Extraction Spoon and the Extraction<br />

Hook.<br />

Select the correct instrument and<br />

attach it to the rod using the threaded<br />

end.<br />

Check secure fixation with the 8mm<br />

open wrench on the flat parts of the<br />

instruments.<br />

Final impaction of staples can be<br />

carried out using the rod with the<br />

attached Impactor and the Hammer.<br />

The Extraction Spoon is used to lift the<br />

staple off the bone until final<br />

extraction can be carried out using the<br />

Extraction Hook and the slot of the<br />

Hammer over the Universal Rod.<br />

5


Ordering Information - Implants<br />

ELLISON Arched Bridge <strong>Fixation</strong> <strong>Staple</strong>s<br />

WIRE <strong>Staple</strong>s<br />

Vitallium Step <strong>Staple</strong> <strong>Staple</strong><br />

Alloy Size Width Length<br />

REF mm mm mm<br />

6982-1-009 N/A 9 23<br />

6982-1-012 N/A 12 23<br />

6982-1-015 N/A 15 23<br />

Vitallium Step <strong>Staple</strong> <strong>Staple</strong><br />

Alloy Size Width Length<br />

REF mm mm mm<br />

6586-1-005 N/A 10 16<br />

6586-2-005 N/A 16 16<br />

6586-3-005 N/A 22 16<br />

ELLISON Flat Bridge <strong>Fixation</strong> <strong>Staple</strong>s<br />

Vitallium Step <strong>Staple</strong> <strong>Staple</strong><br />

Alloy Size Width Length<br />

REF mm mm mm<br />

6982-2-008 N/A 8 23<br />

6982-2-011 N/A 11 23<br />

6982-2-014 N/A 14 23<br />

FRACTURE <strong>Staple</strong>s Straight<br />

Vitallium Step <strong>Staple</strong> <strong>Staple</strong><br />

Alloy Size Width Length<br />

REF mm mm mm<br />

6986-0-005 N/A 16 22<br />

6986-0-007 N/A 22 22<br />

ELLISON Optional Soft Tissue Retainers<br />

Vitallium Step <strong>Staple</strong> <strong>Staple</strong><br />

Alloy Size Width Length<br />

REF mm mm mm<br />

6982-3-008 N/A 8 N/A<br />

6982-3-011 N/A 11 N/A<br />

6982-3-014 N/A 14 N/A<br />

DEPALMA Soft Tissue <strong>Staple</strong>s<br />

Vitallium Step <strong>Staple</strong> <strong>Staple</strong><br />

Alloy Size Width Length<br />

REF mm mm mm<br />

6985-3-003 N/A 10 19<br />

6985-3-006 N/A 19 19<br />

BLOUNT <strong>Staple</strong>s Epiphyseal (with reinforced corners)<br />

Vitallium Step <strong>Staple</strong> <strong>Staple</strong><br />

Alloy Size Width Length<br />

REF mm mm mm<br />

6985-0-003 N/A 10 22<br />

6985-0-005 N/A 16 22<br />

6985-0-007 N/A 22 22<br />

6985-0-011 N/A 27 22<br />

KREMSER* High Tibial Osteotomy <strong>Staple</strong><br />

Vitallium Step <strong>Staple</strong> <strong>Staple</strong><br />

Alloy Size Width Length<br />

REF mm mm mm<br />

6987-7-035 14 35 38<br />

Note: *ISO 4.5mm Cortical Screw recommended<br />

STEPPED High Tibial Osteotomy <strong>Staple</strong>s<br />

Vitallium Step <strong>Staple</strong> <strong>Staple</strong><br />

Alloy Size Width Length<br />

REF mm mm mm<br />

6987-1-005 5 28 33<br />

6987-3-010 10 28 38<br />

6987-5-015 15 28 43<br />

6


Ordering Information - Instruments<br />

REF<br />

Description<br />

6983-1000 Universal Inserter<br />

6983-1010 Clamping Jaws, blue (for Blount, Stepped, Fracture and Kremser <strong>Staple</strong>s)<br />

6983-1020 Clamping Jaws, yellow (for Ellison <strong>Staple</strong>s)<br />

6983-1030 Clamping Jaws, green (for Depalma and Wire <strong>Staple</strong>s)<br />

1806-0113 Universal Rod<br />

6983-3000 Final Impactor<br />

6983-4000 Extraction Spoon<br />

6983-4050 Extraction Hook<br />

1806-0130 Open Wrench 8/10<br />

6983-5000 Slotted Hammer, small<br />

6983-9000 Storage Case with Tray Insert, Implants<br />

6983-9100 Tray Insert, Implants<br />

Optional<br />

6983-2000 Swivel Drill Guide for 2.5mm Drill<br />

Spare Parts<br />

E6983101<br />

E6983102<br />

E6983103<br />

Knob for Universal Inserter<br />

Spring for Universal Inserter<br />

Shaft for Universal Inserter<br />

7


Trauma, Extremities & Deformities<br />

Trauma, Extremities & Deformities<br />

Biologics<br />

Biologics<br />

Surgical Products<br />

Surgical Products<br />

Neuro & ENT<br />

Neuro & ENT<br />

<strong>Stryker</strong> Trauma GmbH<br />

Prof.-Küntscher-Strasse 1-5<br />

D-24232 Schönkirchen<br />

Germany<br />

www.osteosynthesis.stryker.com<br />

The information presented in this brochure is intended to demonstrate a <strong>Stryker</strong> product. Always refer to the package<br />

insert, product label and/or user instructions before using any <strong>Stryker</strong> product. Surgeons must always rely on their own<br />

clinical judgment when deciding which products and techniques to use with their patients. Products may not be available<br />

in all markets. Product availability is subject to the regulatory or medical practices that govern individual markets. Please<br />

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

<strong>Stryker</strong> Corporation or its subsidiary owns the registered trademark: <strong>Stryker</strong><br />

Literature Number: B1000053<br />

LOT B1007<br />

Copyright © 2007 <strong>Stryker</strong><br />

Printed in Germany

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