DEPUY ORTHOTECH SPIKED WASHER

K983906 · DePuy Orthopaedics, Inc. · HTN · Dec 18, 1998 · Orthopedic

Device Facts

• Record ID: K983906
• Device Name: DEPUY ORTHOTECH SPIKED WASHER
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HTN · Orthopedic
• Decision Date: Dec 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy OrthoTech Spiked Washer is intended for use with a 6.5mm cancellous thread or a 4.5mm cortical thread low profile head screw for fixation of soft tissue, such as tendon and ligaments, to bone in orthopaedic procedures.

Device Story

Circular polyacetal polymer washer; features eight inferior spikes for tissue fixation; central hole for screw insertion. Used in orthopaedic procedures to secure soft tissue (tendons/ligaments) to bone. Operated by surgeons in clinical settings. Device functions as mechanical interface between screw head and soft tissue; spikes provide grip to prevent tissue slippage. Benefits patient by ensuring stable fixation during healing process.

Clinical Evidence

No clinical data. Substantial equivalence is based on design and material similarities to legally marketed predicate devices.

Technological Characteristics

Material: Polyacetal polymer. Design: Circular washer with eight inferior spikes. Dimensions: 8mm and 13.5mm outer diameters. Energy source: None (mechanical). Connectivity: None. Sterilization: Non-sterile, single-use.

Indications for Use

Indicated for fixation of soft tissue, including tendons and ligaments, to bone in orthopaedic procedures using 6.5mm cancellous or 4.5mm cortical low-profile head screws.

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

• Smith-Nephew Acufex® Tibial Anchor Screw & Spiked Washer (K961649)
• Synthes® Spiked Washer (K914472)

Submission Summary (Full Text)

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DEC 18 1998

# K983906

### SUMMARY OF SAFETY AND EFFECTIVENESS

| NAME OF FIRM: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive; P.O. Box 988<br>Warsaw, Indiana 46581-0988 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Sally Foust<br>Sr. Regulatory Submissions Associate<br>DePuy Orthopaedics, Inc.<br>[phone]; FAX [phone]<br>E-mail: [e-mail] |
| TRADE NAME: | DePuy OrthoTech Spiked Washer |
| COMMON NAME: | Spiked Washer |
| CLASSIFICATION: | 888.03030 - Single/multiple component, metallic<br>bone fixation appliances and accessories |
| DEVICE PRODUCT CODE: | 87 HTN, HWC |

## SUBSTANTIALLY

#### EQUIVALENT DEVICES:

Smith-Nephew Acufex® Tibial Anchor Screw & Spiked Washer (K961649) Synthes® Spiked Washer (K914472)

## DEVICE DESCRIPTION AND INTENDED USE:

The DePuy OrthoTech Spiked Washer is a circular device with eight inferior (fixative surface) spikes and a central hole for screw insertion. The DePuy OrthoTech Spiked Washer is manufactured from polyacetal polymer and is available in two outer diameters, 8mm and 13.5mm.

The DePuy OrthoTech Spiked Washer is intended for use with a 6.5mm cancellous thread or a 4.5mm cortical thread low profile head screw for fixation of soft tissue, such as tendon and ligaments, to bone in orthopaedic procedures.

### BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy OrthoTech Spiked Washer is substantially equivalent to both the Smith & Nephew Acufex Spiked Washer and the Synthes Spiked Washer in that all are circular washers designed with fixative surface spikes, are manufactured from polyacetal polymer, and are intended for use with screws for fixation of soft tissue, such as tendon and ligaments, to bone in orthopaedic procedures.

Based on similarities of design, materials and intended use, DePuy believes that the subject spiked washer is substantially equivalent to the previously cleared Smith & Nephew Acufex Tibial Spiked Washer and Synthes Spiked Washer.

The table on the following page summarizes the similarities:

OK
TI

000003

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| | DePuy OrthoTech<br>Spiked Washer | Acufex® Tibial<br>Anchor Screw &<br>Spiked Washer | Synthes (USA)<br>Spiked Washer |
|-----------------------------|----------------------------------|---------------------------------------------------|--------------------------------|
| | (Current) | (K961649) | (K914472) |
| MATERIAL | Polyacetal Polymer | Polyacetal Polymer | Polyacetal Polymer |
| IINTENDED<br>USE | Soft Tissue Fixation | Soft Tissue Fixation | Ligament Fixation |
| PRODUCT<br>CODE | HTN<br>HWC | HWC | HTN |
| USE WITH<br>SCREWS | Yes | Yes | Yes |
| WASHER<br>DESIGN | Circular<br>With Spikes | Circular<br>With Spikes | Circular<br>With Spikes |
| WASHER<br>OUTER<br>DIAMETER | 8mm<br>13.5mm | 14-20mm | 13.5mm |
| LABELING | Non-Sterile,<br>Single Use | Sterile,<br>Single Use | Sterile,<br>Single Use |

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Image /page/2/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 eagle with three lines forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 18 1998

Ms. Sally Foust Senior Regulatory Submissions Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive 46581-0988 Warsaw, Indiana

K983906 Re: DePuy OrthoTech Spiked Washer Trade Name: Regulatory Class: II Product Code: HWC Dated: November 2, 1998 November 3, 1998 Received:

Dear Ms. Foust:

We have reviewed your Section 510(k) 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Sally Foust

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

[signature]

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

Enclosure

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510(k) Number (if known) _ k 983906_

Device Name DePuy OrthoTech Spiked Washer

Indications for Use:

The DePuy OrthoTech Spiked Washer is intended for use with a 6.5mm cancellous thread or a 4.5mm cortical thread low profile head screw for fixation of soft tissue, such as tendon and ligaments, to bone in orthopaedic procedures.

Concurrence of CDRH, Office of Device Evaluation

==============================================================================================================================================================================

Prescription Use _ X

OR

Over-The Counter Use __

(Per 21 CFR 801.109)

bcastillo

(Division Sign-Off) Division of General Restorative Devices

510(k) Number