SPIKED WASHER

K011583 · Synthes (Usa) · HTN · Jan 30, 2002 · Orthopedic

Device Facts

• Record ID: K011583
• Device Name: SPIKED WASHER
• Applicant: Synthes (Usa)
• Product Code: HTN · Orthopedic
• Decision Date: Jan 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Spiked Washer is intended for use in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.

Device Story

The Synthes Spiked Washer is a mechanical orthopedic fixation device used for ligament reattachment or fixation. It features spikes designed to link the washer to the ligament, with integrated flats at the base of each spike to limit penetration and prevent excessive compression. The device is available in multiple sizes (8.0 mm or 13.5 mm outer diameter) with varying spike counts (6 or 8 spikes). It is intended for use by surgeons in clinical settings to facilitate the readaptation of torn or avulsed ligaments. The device provides a stable mechanical interface to secure ligamentous tissue during the healing process.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Polyetheretherketone (PEEK) with 6% barium sulfate. Dimensions: 8.0 mm OD/3.2 mm ID (6 spikes) and 13.5 mm OD/4.0 mm ID or 6.0 mm ID (8 spikes). Mechanical fixation via spikes with depth-limiting flats.

Indications for Use

Indicated for ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.

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

• Synthes (USA) Spiked Washer (K011583)

Submission Summary (Full Text)

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JAN 3 0 2002

K011583

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3.0 510(k) Summary

| SPONSOR: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone]<br>Contact: Thomas M. Maguire |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Spiked Washer |
| CLASSIFICATION: | Class II, Section 888.3030, Single/multiple component metallic bone<br>fixation appliances and accessories. |
| PREDICATE DEVICE: | Synthes (USA) Spiked Washer |
| DEVICE DESCRIPTION: | The Spiked Washer is available in the following sizes: 8.0 mm OD / 3.2mm<br>ID (6 spikes), 13.5 mm OD / 4.0 mm ID (8 spikes), and 13.5 mm OD / 6.0<br>mm ID (8 spikes). The spikes provide a link between the washer and the<br>ligament, with flats at the base of each spike to limit penetration into the<br>ligament and prevent excessive compression. The Spiked Washer is<br>manufactured from a polyetheretherketone resin containing 6% barium<br>sulfate. |
| INTENDED USE: | The Synthes Spiked Washer is intended for use in ligament reattachment or<br>fixation, specifically readaptation of torn or avulsed ligaments. |
| MATERIAL: | Polyetheretherketone + 6% Barium Sulfate<br>PEEK |

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human face in profile, with three curved lines representing the hair and face. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 2002

Mr. Thomas M. Maguire Regulatory Compliance Manager Synthes (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301

Re: K011583

Trade/Device Name: Synthes Spiked Washer Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: HTN

Dated: November 2, 2001 Received: November 6, 2001

Dear Mr. Maguire:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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. Iisting 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 - Mr. Thomas M. Maguire

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter wilf anow you to oegin mains of substantial equivalence of your device to a legally prematics notification: "The Pro Intelling of casification 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 11 you desire specific arris09.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Far 00710 101 111 mily, for questions on the promotion and advertising of Compliance at [phone]. Free of Compliance at [phone]. Also, please note the your dones, pread combranding by reference to premarket notification" (21CFR Part 807.97). regulation on thinked, "Thisorange responsibilities under the Act may be obtained from the Other general mionnation on your new 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,

L. Mark A. Milburn

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement 2.0

> Page _________________________________________________________________________________________________________________________________________________________________________

| 510(k) Number (if known): | K011168 |
|---------------------------|---------|
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Synthes (USA) Spiked Washer Device Name:

Indications/Contraindications:

Synthes Spiked Washer is intended for use in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.

(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)

OR

Over-The-Counter Use_No

Mark A. Millman

Division Sign Division of General, Restorative and Neurological Devices

KOIIS83

510(k) Number -

Confidential