ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS

K031666 · Arthrex, Inc. · HRS · Nov 18, 2003 · Orthopedic

Device Facts

• Record ID: K031666
• Device Name: ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS
• Applicant: Arthrex, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Nov 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex ACL RetroConstruction™ Button Kit for fixation of bone to bone or soft tissue to bone is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons and recommending use of size 2 or size 5 FiberWire™ or equivalent. Specifically, Arthrex will be offering this for ACL repair.

Device Story

Device consists of titanium buttons used for orthopedic fixation; buttons feature 2 or 4 holes for suture passage. Used in conjunction with FiberWire™ (size 2 or 5) to secure soft tissue to bone or bone to bone. Operated by surgeons in clinical/OR settings during ACL repair procedures. Functions as a fixation post or distribution bridge to manage suture tension. Benefits patient by providing stable fixation during ligament/tendon healing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Titanium 6AL4V ELI. Form factor: Metal buttons with 2 or 4 holes. Mechanical fixation device; no energy source or software.

Indications for Use

Indicated for fixation of bone to bone or soft tissue to bone, specifically for ACL repair, in patients requiring ligament or tendon repair.

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

• Arthrex (K010673)
• Arthrex (K012923)
• Arthrex (K021434)
• Smith & Nephew (K980155)
• Karl Storz Endoscopy-America, Inc. (K022853)
• DePuy ACE (K990120)
• DePuy ACE (K982347)
• Bonutti Research (K990156)

Submission Summary (Full Text)

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NOV 1 8 2003

K031666
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## 510(k) Summary

| 510(k) Number: | K031666 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ann Waterhouse, Regulatory Affairs Specialist |
| Date Prepared: | June 2003 |
| Trade/Proprietary Name: | Arthrex ACL RetroConstruction™ Button Kit |
| Product Code: | HRS |
| Classification Name: | Plate, Fixation, Bone |
| Predicate Devices: | Arthrex K010673, Arthrex K012923, Arthrex K021434,<br>Smith & Nephew K980155, Karl Storz Endoscopy-<br>America, Inc. K022853, DePuy ACE K990120, DePuy<br>ACE K982347, and Bonutti Research K990156. |

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

#### Intended Use:

The Arthrex ACL RetroConstruction™ Button Kit for fixation of bone to bone or soft tissue to bone is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons and recommending use of size 2 or size 5 FiberWire™ or equivalent. Specifically, Arthrex will be offering this for ACL repair.

#### Description:

Arthrex, Inc. ACL RetroConstruction™ Button Kit consists of metal buttons. These buttons are Titanium 6AL4V ELI and have either 2 or 4 holes for inclusion of suture. The suture recommended for use with this kit is FiberWire™, an Arthrex product, which is offered in various sizes and configurations.

#### Substantial Equivalence:

The Arthrex, Inc. ACL RetroConstruction ™ Button kit is substantially equivalent to predicate devices where the basic features and intended uses are the same. Minor differences between the Arthrex device and predicate devices do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function, or intended use of this device.

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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 eagle with three human profiles incorporated into its design. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Public Health Service

NOV 1 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Ann Waterhouse Regulatory Affairs Specialist Arthrex Inc. 2885 South Horseshoe Drive Naples, Florida 34104

Re: K031666 Trade/Device Name: Arthrex Fiberwire™ Button Repair Kit Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: HRS, GAT Dated: September 25, 2003 Received: September 26, 2003

Dear Ms. Waterhouse:

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, 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 - Ms. Ann Waterhouse

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 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594- 4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Sincerely yours,

Mark A. Milken

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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# 510(k) Number (if known):

### Device Name: Arthrex Fiberwire™ Button Repair Kit

Indications for Use:

The Arthrex ACL RetroConstruction™ Button Kit for fixation of bone to bone or soft tissue to bone is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons and recommending use of size 2 or size 5 FiberWire™ or equivalent. Specifically, Arthrex will be offering this for ACL repair.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Option Format 3-10-98)

Mark n Millen
Division Six of

25 orative (k) Number _____