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SURGICAL TECHNIQUEIntegra® Stainless Headed Compression Screw System
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Table of ContentsDesign Rationale ...................................................................................................................................................................................................2Indications .............................................................................................................................................................................................................2Contraindications .................................................................................................................................................................................................2
Surgical TechniqueStep 1: Inserting Guide Wire ............................................................................................................................................................................... 3Step 2: Pre-Drilling (Optional) ............................................................................................................................................................................4Step 3: Countersinking Screw Head (Optional) ...............................................................................................................................................4Step 4: Measuring Screw Length .......................................................................................................................................................................4Step 5: Inserting The Screw ................................................................................................................................................................................4
4.0mm/4.5mm Stainless Headed Compression Screw Instrument Set ....................................................................................................... 56.5mm/7.5mm Stainless Headed Compression Screw Instrument Set .......................................................................................................64.0mm/4.5mm Integra Stainless Headed Compression Screw System ....................................................................................................... 76.5mm/7.5mm Integra Stainless Headed Compression Screw System .......................................................................................................9
Stainless Headed Compression Screw Precautions ...................................................................................................................................... 10
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Design Rationale
The Integra® 4.0mm/4.5mm Stainless Headed Compression Screw System consists of headed cannulated screws of 4.0mm and 4.5mm diameters. The Integra 6.5mm/7.5mm Stainless Headed Compression Screw System consists of headed cannulated screws of 6.5mm and 7.5mm diameters. All screws are designed to be self drilling with special cutting grooves that allows the screw to drill easily into the bone. Pre-drilling is recommended for juvenile or hard bone. Screws are self tapping both forward and backward, which facilitates easy removal.
The implants, K-wires and drills are provided non-sterile and are single-use only. Instrumentation is provided to assist in the surgical implantation of the implants. It is important that the instruments used are those specifically designed for this device to ensure accurate installation.
Indications
The cannulated screws are intended for use over a guide pin or wire for bone fracture fixation and bone fragment fixation. The washers may be used with the screws in certain applications.
The indications for the Integra Stainless Headed Compression Screws (Ø 4.0mm, 4.5mm, 6.5mm, and 7.5mm) include:
• Minimally invasive reconstruction of fractures and joints• Adjuvant for osteosynthesis in complex joint fractures• Multi-fragment joint fractures• Simple metaphyseal fractures• Simple epiphyseal fractures such as:
» Fractures of the humeral head » Pilon fractures » Fractures of the radius
• Fractures of the wrist, ankle, elbow, and shoulder• Metatarsal fractures and other fractures of the foot• Condylar fractures• Ligament avulsion injuries• Fractures of small joints, such as:
» Ankle fractures » Navicular fractures
• Calcaneal and talar fractures• Arthrodesis of the ankle
Contraindications
Inflammation, sepsis and osteomyelitis are absolute contraindications.Any other applications not covered by the indications and the medical literature are also contraindicated.In addition, the success of the operation may also be affected by:
• Unacceptably high risk for anesthesia• Inadequate soft tissue coverage• Acute or chronic systemic or localized infection / inflammation• Vascular, muscular or neurologic disorders impairing the affected limb• Any concomitant disorders possibly affecting implant function• Osteopathy with loss of bone substance, such as severe osteoporosis• Obesity: an obese patient may overload the implant to the point where the fixation or implant may fail• Whenever the implant is impairing the anatomical structures or normal physiology
Caution: Federal law restricts this device to sale by or on the order of a physician or practitioner.See package insert for full prescribing information
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Surgical Technique
As the manufacturer of this device, Integra does not practice medicine and does not recommend this or any other surgical technique for use on a specific patient. The surgeon who performs any procedure is responsible for determining and using the appropriate technique in each patient.
Step 1 • Inserting Guide Wire
1 - 2 Use of the Parallel Drill Guide: for 4.0 and 4.5mm Screws
Unscrew the retaining nut of the parallel drill guide insert. Place the drill guide insert into the oblong hole of the parallel drill guide and secure with the retaining nut. Advance parallel drill guide along the guide wire. Fix desired position by moving the drill guide insert along the oblong hole and tighten the retaining nut.
Insert the obturator into the circular hole on parallel drill guide. Advance K-wire through the obturator. Remove parallel drill guide insert and continue with screw length measurement.
1 - 3 Use of the Parallel Drill Guide: for 6.5mm and 7.5mm Screws
Advance the parallel drill guide along the K-wire. Advance additional K-wires through the holes in the parallel drill guide. Remove parallel drill guide insert and continue with screw length measurement.
NOTE: The position of the K-wire defines the final position of the cannulated screw in the bone.
1 - 1 Initial incision is made. Insert the obturator into the tissue protector, ensuring it is flush with the bone surface. Advance K-wire through the obturator using gentle and steady pressure to avoid bending the guide wire. Once appropriate reduction is achieved, remove the obturator from the tissue protector.
Screw Diameter K-Wire Diameter
4.0mm 1.2mm
4.5mm 1.6mm
6.5mm 2.5mm
7.5mm 3.0mm
NOTE: Always use a pre-measured K-wire. Manufacturing tolerances may influence the measurement and choice of the correct screw length.
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1 - 2
1 - 3
K-Wire Reference Guide
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Step 2 • Pre-Drilling (Optional)
2 - 1 Although the screws are designed to be self drilling, pre-drilling is recommended for juvenile or hard bone to prevent damage to the screw during insertion as well as a loss of reduction due to the applied forces.
2 - 2 Use the cannulated drill bit that coincides with the appropriate screw diameter and respective drill sleeve. In order to avoid damaging the drill or K-wire, use low speed or drill manually using the ratcheting handle. Apply pressure continuously.
2 - 3 Remove tissue protector and drill sleeve.
Step 3 • Countersinking Screw Head (Optional)
3 - 1 When soft-tissue coverage and/or screw position demands further recess of the screw head, the countersink may be used.
If the angle of approach is too steep, the proximal cortex can be pre-drilled or the countersink may be utilized. Ideally, all screw cutting flutes should grip simultaneously to avoid damage to the screw.
This step should be done prior to measuring as it may affect the correct screw length determination.
4 - 1
2- 1
3 - 1
Step 4 • Measuring Screw Length
4 - 1 Slide the direct measuring device over the K-wire down to the bone. This will provide an accurate measurement of the required screw length.
Step 5 • Inserting The Screw
5 - 1 Assemble the appropriate driver to the ratcheting handle. Slide the screw and the assembled screwdriver over the K-wire onto the bone. Insert the screw by turning the screwdriver clockwise. Always insert the screws manually. Using a power driver is not recommended. Once the screw is inserted, remove the K-wire.
For screw removal, always use a non-cannulated screwdriver.
NOTE: In case the screw penetrates the bone too deeply, washers can be used to salvage the screw fixation and reduce tension peaks between the bone and screw head. Remove the screw with the K-wire still in place, slide the washer over the screw and reinstall.
5 - 1
Make sure to account for potential deviations from compression and use of washers. Ensure that no soft tissue or liquid exists between the bone and the measuring device as it will alter the screw measurement.
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4.0mm/4.5mm Stainless Headed Compression Screw Instrument Set
1. Threaded K-wire, Ø1.6, L 150 2. K-wire, Ø1.2, L 1503. Cleaning Wire 4.5, Ø1.64. Cleaning Wire 4.0, Ø1.25. Screwdriver Cannulated 4.5, Hexagonal, ø2.56. Screwdriver Cannulated 4.0, Hexagonal, ø2.57. Drill 4.0, Ø2.58. Drill 4.5, Ø3.09. Drill 4.5, Ø4.510. Drill 4.0, Ø4.011. Countersink12. Staple for Washers13. Screw Forceps14. Direct Measuring Device 15. 4.0mm Cannulated Screws, Short Thread16. 4.0mm Cannulated Screws, Full Thread17. 4.5mm Cannulated Screws, Short Thread18. 4.5mm Cannulated Screws, Full Thread19. Drill Guide Insert, 4.020. Drill Guide Insert, 4.521. Obturator, 4.022. Obturator, 4.523. Drill Sleeve 4.0, Ø2.624. Drill Sleeve 4.5, Ø3.125. Drill Sleeve 4.0, Ø4.126. Drill Sleeve 4.5, Ø4.627. Tissue Protection Sleeve28. Parallel Drill Guide29. Ratcheting Handle
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2625
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6.5mm/7.5mm Stainless Headed Compression Screw Instrument Set
1. Cannulated Drill 7.5, Ø5.0, L 220 2. Cannulated Drill 6.5, Ø4.4, L 220 3. Countersink, 6.5/7.5 4. Screwdriver Cannulated 6.5/7.5, hex Ø5.0 5. Washer I- Ø8.3, O- Ø13.0 6. Drill Sleeve 7.5 7. Drill Sleeve 6.5 8. Tissue Protection Sleeve 6.5/7.5 9. Cannulated screwdriver 6.5/7.5, T-handle 10. Screw Holding Forceps 11. 6.5mm Cannulated Screws, Full Thread12. 6.5mm Cannulated Screws, TL3213. 6.5mm Cannulated Screws, TL1614. 7.5mm Cannulated Screws, Full Thread15. 7.5mm Cannulated Screws, TL3216. 7.5mm Cannulated Screws, TL1617. Cleaning Wire 6.5, Ø2.518. Cleaning Wire 7.5, Ø3.0 19. K-wire Ø3.0mm, L 270 20. K-wire Ø2.5mm, L 270 21. Direct Measuring Device, 6.5/7.522. Ratcheting Handle23. Parallel Guide for K-wires, 6.5/7.5 24. Obturator, 6.525. Obturator, 7.5
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4.0mm/4.5mm Integra Stainless Headed Compression Screw System
Screws – 4.0mm Full Thread
440610 Cannulated Screw 4.0, L 10, full thread440612 Cannulated Screw 4.0, L 12, full thread440614 Cannulated Screw 4.0, L 14, full thread440616 Cannulated Screw 4.0, L 16, full thread440618 Cannulated Screw 4.0, L 18, full thread440320 Cannulated Screw 4.0, L 20, full thread440322 Cannulated Screw 4.0, L 22, full thread440324 Cannulated Screw 4.0, L 24, full thread440326 Cannulated Screw 4.0, L 26, full thread440328 Cannulated Screw 4.0, L 28, full thread440330 Cannulated Screw 4.0, L 30, full thread440332 Cannulated Screw 4.0, L 32, full thread440334 Cannulated Screw 4.0, L 34, full thread440336 Cannulated Screw 4.0, L 36, full thread440338 Cannulated Screw 4.0, L 38, full thread440040 Cannulated Screw 4.0, L 40, full thread440642 Cannulated Screw 4.0, L 42, full thread440644 Cannulated Screw 4.0, L 44, full thread440646 Cannulated Screw 4.0, L 46, full thread440648 Cannulated Screw 4.0, L 48, full thread440650 Cannulated Screw 4.0, L 50, full thread
Screws – 4.0mm Short Thread
440210 Cannulated Screw 4.0, L 10, TL 5, short thread440112 Cannulated Screw 4.0, L 12, TL 5, short thread440214 Cannulated Screw 4.0, L 14, TL 5, short thread440116 Cannulated Screw 4.0, L 16, TL 6, short thread440218 Cannulated Screw 4.0, L 18, TL 7, short thread440120 Cannulated Screw 4.0, L 20, TL 8, short thread440122 Cannulated Screw 4.0, L 22, TL 9, short thread440124 Cannulated Screw 4.0, L 24, TL 10, short thread440126 Cannulated Screw 4.0, L 26, TL 12, short thread440128 Cannulated Screw 4.0, L 28, TL 14, short thread440230 Cannulated Screw 4.0, L 30, TL 14, short thread440132 Cannulated Screw 4.0, L 32, TL 15, short thread440234 Cannulated Screw 4.0, L 34, TL 15, short thread440136 Cannulated Screw 4.0, L 36, TL 15, short thread440238 Cannulated Screw 4.0, L 38, TL 16, short thread440240 Cannulated Screw 4.0, L 40, TL 16, short thread440142 Cannulated Screw 4.0, L 42, TL 16, short thread440144 Cannulated Screw 4.0, L 44, TL 17, short thread440146 Cannulated Screw 4.0, L 46, TL 17, short thread440148 Cannulated Screw 4.0, L 48, TL 18, short thread440250 Cannulated Screw 4.0, L 50, TL 18, short thread
Catalog Number Description Catalog Number Description
Catalog Number Description Catalog Number Description
Screws – 4.5mm Full Thread
445320 Cannulated Screw 4.5, L 20, full thread445322 Cannulated Screw 4.5, L 22, full thread445324 Cannulated Screw 4.5, L 24, full thread445326 Cannulated Screw 4.5, L 26, full thread445328 Cannulated Screw 4.5, L 28, full thread445330 Cannulated Screw 4.5, L 30, full thread445332 Cannulated Screw 4.5, L 32, full thread445334 Cannulated Screw 4.5, L 34, full thread445336 Cannulated Screw 4.5, L 36, full thread445338 Cannulated Screw 4.5, L 38, full thread445340 Cannulated Screw 4.5, L 40, full thread445342 Cannulated Screw 4.5, L 42, full thread445344 Cannulated Screw 4.5, L 44, full thread445346 Cannulated Screw 4.5, L 46, full thread445348 Cannulated Screw 4.5, L 48, full thread445350 Cannulated Screw 4.5, L 50, full thread445352 Cannulated Screw 4.5, L 52, full thread445354 Cannulated Screw 4.5, L 54, full thread445356 Cannulated Screw 4.5, L 56, full thread445360 Cannulated Screw 4.5, L 60, full thread445364 Cannulated Screw 4.5, L 64, full thread445368 Cannulated Screw 4.5, L 68, full thread445372 Cannulated Screw 4.5, L 72, full thread
Screws – 4.5mm Short Thread
445120 Cannulated Screw 4.5, L 20, TL 7, short thread445122 Cannulated Screw 4.5, L 22, TL 7, short thread445124 Cannulated Screw 4.5, L 24, TL 8, short thread445126 Cannulated Screw 4.5, L 26, TL 9, short thread445128 Cannulated Screw 4.5, L 28, TL 9, short thread445130 Cannulated Screw 4.5, L 30, TL 10, short thread445132 Cannulated Screw 4.5, L 32, TL 11, short thread445134 Cannulated Screw 4.5, L 34, TL 11, short thread445136 Cannulated Screw 4.5, L 36, TL 12, short thread445138 Cannulated Screw 4.5, L 38, TL 13, short thread445140 Cannulated Screw 4.5, L 40, TL 13, short thread445142 Cannulated Screw 4.5, L 42, TL 14, short thread445144 Cannulated Screw 4.5, L 44, TL 15, short thread445146 Cannulated Screw 4.5, L 46, TL 15, short thread445148 Cannulated Screw 4.5, L 48, TL 16, short thread445150 Cannulated Screw 4.5, L 50, TL 16, short thread445152 Cannulated Screw 4.5, L 52, TL 17, short thread445154 Cannulated Screw 4.5, L 54, TL 18, short thread445156 Cannulated Screw 4.5, L 56, TL 19, short thread445160 Cannulated Screw 4.5, L 60, TL 20, short thread445164 Cannulated Screw 4.5, L 64, TL 21, short thread445168 Cannulated Screw 4.5, L 68, TL 23, short thread445172 Cannulated Screw 4.5, L 72, TL 24, short thread
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Catalog Number Description
Implants
430290 Washer, I-ø4.5, O-ø8.0
Instruments
430100 Tissue protection sleeve CS 2.7-4.5430110 Obturator CS 2.7-4.0430115 Obturator CS 4.5430130 Drill sleeve CS 4.0, I-ø2.6430131 Drill sleeve CS 4.0, I-ø4.1430132 Drill Sleeve CS 4.5, I-ø3.1430170 Drill sleeve CS 4.5, I-ø4.6430180 Screwdriver cannulated CS 2.7-4.0, hexagonal, ø2.5, quick coupling430190 Screwdriver cannulated CS 4.5, hexagonal, ø2.5, quick coupling430195 Countersink CS 2.7-4.5, quick coupling430205 Parallel drill guide CS 3.5-4.5, basic device430223 Drill guide insert, CS 2.7-4.0430230 Drill guide insert CS 4.5430235 Cleaning wire ø1.2, CS 2.7-4.0430260 Cleaning wire ø1.6, CS 4.5430425 Drill CS 4.0, ø2.5, L 130, quick coupling, single use430453 Drill CS 4.5, ø3.0, L 130, quick coupling, single use430404 Drill CS 4.0, ø4.0, L 130, quick coupling, single use430455 Drill CS 4.5, ø4.5, L 130, quick coupling, single use430270 Direct measuring device, L 150, CS 2.7-4.5, closed430280 Screw forceps, self-holding430125 K-wire with trocar point, ø1.2, L 150 430165 K-wire with trocar point and thread, ø1.6, L 150 430310 Staple for washers430330 Ratcheting Handle with quick coupling
Tray
430445 4.0mm/4.5mm Stainless Headed Compression Screw Instrument Case - Complete430446 4.0mm/4.5mm Tray Lid430447 4.0mm/4.5mm Tray Base430448 4.0mm Screw Caddy430449 4.5mm Screw Caddy430451 4.0mm/4.5mm Instrument Insert
Component MaterialsScrews: Stainless Steel
Catalog Number Description
Catalog Number Description
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6.5mm/7.5mm Integra Stainless Headed Compression Screw System
Screws – 6.5mm Full Thread
465630 Cannulated screw 6.5, full thread, L 30465635 Cannulated screw 6.5, full thread, L 35465640 Cannulated screw 6.5, full thread, L 40465645 Cannulated screw 6.5, full thread, L 45465650 Cannulated screw 6.5, full thread, L 50465655 Cannulated screw 6.5, full thread, L 55465660 Cannulated screw 6.5, full thread, L 60465665 Cannulated screw 6.5, full thread, L 65465670 Cannulated screw 6.5, full thread, L 70465675 Cannulated screw 6.5, full thread, L 75465680 Cannulated screw 6.5, full thread, L 80465685 Cannulated screw 6.5, full thread, L 85465690 Cannulated screw 6.5, full thread, L 90465695 Cannulated screw 6.5, full thread, L 95465600 Cannulated screw 6.5, full thread, L 100465605 Cannulated screw 6.5, full thread, L 105465610 Cannulated screw 6.5, full thread, L 110465615 Cannulated screw 6.5, full thread, L 115465620 Cannulated screw 6.5, full thread, L 120
Screws – 6.5mm, TL32
465345 Cannulated screw 6.5, TL 32, L 45465350 Cannulated screw 6.5, TL 32, L 50465355 Cannulated screw 6.5, TL 32, L 55465360 Cannulated screw 6.5, TL 32, L 60465365 Cannulated screw 6.5, TL 32, L 65465370 Cannulated screw 6.5, TL 32, L 70465375 Cannulated screw 6.5, TL 32, L 75465380 Cannulated screw 6.5, TL 32, L 80465385 Cannulated screw 6.5, TL 32, L 85465390 Cannulated screw 6.5, TL 32, L 90465395 Cannulated screw 6.5, TL 32, L 95465300 Cannulated screw 6.5, TL 32, L 100465305 Cannulated screw 6.5, TL 32, L 105465310 Cannulated screw 6.5, TL 32, L 110465315 Cannulated screw 6.5, TL 32, L 115465320 Cannulated screw 6.5, TL 32, L 120
Screws – 6.5mm, TL16
465130 Cannulated screw 6.5, TL 16, L 30465135 Cannulated screw 6.5, TL 16, L 35465140 Cannulated screw 6.5, TL 16, L 40465145 Cannulated screw 6.5, TL 16, L 45465150 Cannulated screw 6.5, TL 16, L 50465155 Cannulated screw 6.5, TL 16, L 55465160 Cannulated screw 6.5, TL 16, L 60465165 Cannulated screw 6.5, TL 16, L 65465170 Cannulated screw 6.5, TL 16, L 70465175 Cannulated screw 6.5, TL 16, L 75465180 Cannulated screw 6.5, TL 16, L 80465185 Cannulated screw 6.5, TL 16, L 85465190 Cannulated screw 6.5, TL 16, L 90465195 Cannulated screw 6.5, TL 16, L 95465100 Cannulated screw 6.5, TL 16, L 100465105 Cannulated screw 6.5, TL 16, L 105465110 Cannulated screw 6.5, TL 16, L 110465115 Cannulated screw 6.5, TL 16, L 115465120 Cannulated screw 6.5, TL 16, L 120
Catalog Number Description
Screws – 7.5mm Full Thread
475630 Cannulated screw 7.5, full thread, L 30475435 Cannulated screw 7.5, full thread, L 35475640 Cannulated screw 7.5, full thread, L 40475645 Cannulated screw 7.5, full thread, L 45475650 Cannulated screw 7.5, full thread, L 50475655 Cannulated screw 7.5, full thread, L 55475660 Cannulated screw 7.5, full thread, L 60475665 Cannulated screw 7.5, full thread, L 65475670 Cannulated screw 7.5, full thread, L 70475675 Cannulated screw 7.5, full thread, L 75475680 Cannulated screw 7.5, full thread, L 80475685 Cannulated screw 7.5, full thread, L 85475690 Cannulated screw 7.5, full thread, L 90475695 Cannulated screw 7.5, full thread, L 95475600 Cannulated screw 7.5, full thread, L 100475605 Cannulated screw 7.5, full thread, L 105475610 Cannulated screw 7.5, full thread, L 110475615 Cannulated screw 7.5, full thread, L 115475620 Cannulated screw 7.5, full thread, L 120
Screws – 7.5mm, TL32
475345 Cannulated screw 7.5, TL 32, L 45475350 Cannulated screw 7.5, TL 32, L 50475355 Cannulated screw 7.5, TL 32, L 55475360 Cannulated screw 7.5, TL 32, L 60475365 Cannulated screw 7.5, TL 32, L 65475370 Cannulated screw 7.5, TL 32, L 70475375 Cannulated screw 7.5, TL 32, L 75475380 Cannulated screw 7.5, TL 32, L 80475385 Cannulated screw 7.5, TL 32, L 85475390 Cannulated screw 7.5, TL 32, L 90475395 Cannulated screw 7.5, TL 32, L 95475300 Cannulated screw 7.5, TL 32, L 100475005 Cannulated screw 7.5, TL 32, L 105475410 Cannulated screw 7.5, TL 32, L 110475315 Cannulated screw 7.5, TL 32, L 115475420 Cannulated screw 7.5, TL 32, L 120475325 Cannulated screw 7.5, TL 32, L 125475430 Cannulated screw 7.5, TL 32, L 130
Catalog Number Description Catalog Number Description
Catalog Number Description Catalog Number Description
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Screws – 7.5mm, TL16
475030 Cannulated screw 7.5, TL 16, L 30475135 Cannulated screw 7.5, TL 16, L 35475040 Cannulated screw 7.5, TL 16, L 40475145 Cannulated screw 7.5, TL 16, L 45475250 Cannulated screw 7.5, TL 16, L 50475255 Cannulated screw 7.5, TL 16, L 55475060 Cannulated screw 7.5, TL 16, L 60475265 Cannulated screw 7.5, TL 16, L 65475170 Cannulated screw 7.5, TL 16, L 70475275 Cannulated screw 7.5, TL 16, L 75475280 Cannulated screw 7.5, TL 16, L 80475285 Cannulated screw 7.5, TL 16, L 85475190 Cannulated screw 7.5, TL 16, L 90475195 Cannulated screw 7.5, TL 16, L 95475200 Cannulated screw 7.5, TL 16, L 100475205 Cannulated screw 7.5, TL 16, L 105475210 Cannulated screw 7.5, TL 16, L 110475115 Cannulated screw 7.5, TL 16, L 115475020 Cannulated screw 7.5, TL 16, L 120475225 Cannulated screw 7.5, TL 16, L 125475230 Cannulated screw 7.5, TL 16, L 130
Implants
430490 Washer I-ø8.6, O-ø13.0
Instruments
430340 Drill sleeve CS 6.5430350 Drill sleeve CS 7.5430360 Cleaning wire ø2.5, CS 6.5430370 Cleaning wire ø3.0, CS 6.5430380 Tissue protection sleeve CS 6.5/7.5430390 Obturator CS 6.5430410 Obturator CS 7.5430420 Countersink CS 6.5/7.5, Hudson430430 Screwdriver cannulated CS 6.5/7.5, hex ø5.0, Hudson430440 Parallel guide for K-wires, CS 6.5/7.5430654 Cannulated drill CS 6.5, ø4.4, L 220, Hudson, single use430755 Cannulated drill CS 7.5, ø5.0, L 220, Hudson, single use430450 Direct measuring device CS 6.5/7.5, closed430460 Screw holding forceps430470 K-wire ø2.5 mm, L 270430480 K-wire ø3.0 mm, L 270430500 Ratcheting Handle with Hudson430510 Cannulated screwdriver CS 6.5/7.5, T-handle
Catalog Number Description
Catalog Number Description
Catalog Number Description
Tray
430675 6.5mm/7.5mm Stainless Headed Compression Screw Instrument Case – Complete
430676 6.5mm/7.5mm Tray Lid430677 6.5mm/7.5mm Tray Base430678 6.5mm Screw Caddy430679 7.5mm Screw Caddy430681 6.5mm/7.5mm Insert430682 6.5mm/7.5mm Instrument Insert
Catalog Number Description
Component MaterialsScrews: Stainless Steel
Stainless Headed Compression Screw Precautions
• Cannulated screws, washers and guide wires supplied non-sterile. Therefore, they must be cleaned and sterilized before use. These products are intended for single use only. Integra disclaims any re-use of the implants and of the guide wires for cannulated screws.
• Medical devices may be used only for the functions for which they have been designed. Stainless steel implants should not be combined with titanium implants because of possible galvanic corrosion which might result in implant failure.
• The implant promotes fracture healing through its fixating action. The implant is not designed to withstand continuous loading without osseous support and fracture healing. Medical devices designed for fracture fixation and subjected to fatigue cannot be expected to tolerate the same activities as normal healthy bone. Thus, the system for fracture healing is not as stable, resilient and resistant as normal human bone. Screwdrivers must always be fully inserted into the screw head and in line with the long axis of the screw.
• Before surgery, the surgeon must be well versed in the general surgical procedure and particularly in the surgical technique required for the medical devices used. Careful bone reconstruction and the correct choice and position of the implant are crucial, and after implantation correct placement must be checked. Preoperative planning is recommended for selecting proper implant size and position. Instructions on implant combinations are included in the description of the pertinent surgical technique. Since the system has not tested any combination of medical devices and instruments by other manufacturers, responsibility in this case rests solely with the surgeon.
• This screw system has not been evaluated for safety and compatibility in the MRI environment. This screw system has not been tested for heating or migration in the MRI environment.
Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation. ©2012 Integra LifeSciences Corporation. All rights reserved. Printed in the USA 00001851
For more information or to place an order, please contact:Integra n 311 Enterprise Drive, Plainsboro, NJ 08536877-444-1122 USA n 609-936-5400 outside USA n 866-800-7742 faxintegralife.com
Integra®
Stainless Headed Compression Screw System
