TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM

K013775 · Stryker Leibinger · HRS · Jan 8, 2002 · Orthopedic

Device Facts

• Record ID: K013775
• Device Name: TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM
• Applicant: Stryker Leibinger
• Product Code: HRS · Orthopedic
• Decision Date: Jan 8, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Leibinger, TwinFix® Interfragmentary Compression Screw System is intended to be used for fractures or arthrodesis of carpals and metacarpals, radial head and radial styloid fractures, metatarsal fractures and osteotomies of the forefoot and intra-articular arthrodesis in the wrist.

Device Story

TwinFix® Interfragmentary Compression Screw System is a double cancellous bone thread screw system designed for in situ dynamic adjustable interfragmentary compression. Device features self-tapping screw tip design with varying lengths. Used by surgeons in clinical settings for treatment of small bone fractures, pseudo-arthrosis, and corrective osteotomies. Placement performed via open approach using target bow instrumentation or percutaneous placement guided by K-wire to minimize incision size. Provides stable osteosynthesis to facilitate bone healing.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use similarity to the predicate device.

Technological Characteristics

Metallic bone fixation screw system; double cancellous bone thread design; self-tapping tip; includes target bow instrumentation for placement; manual surgical instrument; non-sterile or sterile (implied by standard orthopedic practice).

Indications for Use

Indicated for patients requiring fixation for fractures, pseudo-arthrosis, degenerative alterations, or corrective osteotomies of small bones, specifically carpals, metacarpals, radial head, radial styloid, metatarsals, and wrist joints.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Resch Arthroscopic and Percutaneous Screw Fixation System (K961498)

Submission Summary (Full Text)

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K∅13775
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#### Jan 8 2002

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS: TwinFix® Interfragmentary Compression Screw System

| Proprietary Name: | TwinFix® Interfragmentary Compression Screw System |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Small Bone Screw System<br>Single/Multiple Component Metallic Bone Fixation<br>Application and Accessories 888.3030<br>Target Bow Instrumentation<br>Orthopedic manual surgical instrument<br>21 CFR 888.4540 Class I exempt |
| Proposed Regulatory Class: | Class II |
| Device Classification: | 87 HRS<br>87 LXH |
| Submitter: | Stryker Leibinger<br>4100 East Milham Avenue<br>Kalamazoo, MI 49001<br>800-253-7370 |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 8010177 |
| Contact Person: | Robin L. Rowe<br>Regulatory Affairs Representative<br>Telephone: [phone] x3295<br>Fax: [phone] |
| Summary Preparation Date: | November 01, 2001 |

510(K) Summary of Safety and Effectiveness TwinFix® Interfragmentary Compression Screw System 1

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013775

## Intended Use

The subject device, TwinFix® Interfragmentary Compression Screw System is Indicated for fractures or arthrodesis of carpais and metacarpals, radial styloid fractures, metatarsal fractures and ostectornies of the forefoot and intra-articular arthrodesis in the wrist.

See Appendix C for equivalency.

### Device Description

The Stryker Leibinger, TwinFix® Interfragmentary Compression Screw System is indicated for the treatment of fractures, psueudo-arthrosis, degenerative alterations and corrective osteotomies alming to a functionally stable osteosysntheis such as, but not limited to: scaphoid fractures, fractures of other carpal bones, scaphoid pseudo-arthrosis, intercarpal arthrodesis of finger end and metacarpal joints and fractures of ulna head and radius head. The TwinFix® is a double cancellous bone thread screw system that is designed for in situ dynamic adjustable interfragmentary compression purposes. It has a self-tapping screw tip design with varying lengths. It may be placed using an open approach with the use of a target bow device for placement of screws or through percutaneous screw placement using K-virre as a guide to minimize the incision.

### Substantial Equivalence

The TwinFix® Interfragmentary Compression Screw is Identical to K961498, Resch Arthroscopic and Percutaneous Screw Fixation System in all respects of fixations of small bones. A table of eguivalency is provided in Appendix C.

Robin L Rowe

Regulatory Affairs Representative December 20, 2001

> 510(K) Summary of Safety and Effectiveness TwinBix® Interfragmentary Compression Screw System 2

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 8 2002

Stryker Leibinger Robin L. Rowe Regulatory Affairs Representative 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K013775

Trade Name: Twinfix Interfragmentary Compression Screw System Regulation Number: 888.3030 Regulation Name: Compression Screw with accessories Regulatory Class: II Product Code: HRS Dated: December 7, 2001 Received: December 11, 2001

Dear Ms. Rowe:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 注 Ms. Robin Rowe

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally promated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# KO13775

510(k) Number (if known):

Page 1 of 1

Device Name: TwinFix® Interfragmentary Compression Screw System

Indication For Use:

The Stryker Leibinger, TwinFix® Interfragmentary Compression Screw System is intended to be used for fractures or arthrodesis of carpals and metacarpals, radial head and radial styloid fractures, metatarsal fractures and osteotomies of the forefoot and intra-articular arthrodesis in the wrist.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH,Office of device Evaluation (ODE)

Prescription Use
(per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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(Division Sign-Off) Division of General. Pastorative and Neurolegican Bookes

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510(k) Number K013775