ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B

K032098 · Arthrex, Inc. · HWC · Oct 7, 2003 · Orthopedic

Device Facts

• Record ID: K032098
• Device Name: ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B
• Applicant: Arthrex, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Oct 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex Bio-Compression Screw is a bioabsorbable polylactide (PLLA) screw intended to provide fixation of small bone fragments such as apical fragments, osteochondral fragments, and cancellous fragments. Specifically; Apical Fragments: Radial Head, Patellar Rim, Navicular, Metacarpal and Metatarsal Osteochondral Fragments: Talar Vault, femoral condvle Cancellous Fragments: Talus

Device Story

Bioabsorbable PLLA screw; provides fixation for small bone fragments; used in orthopedic procedures; sterile; implantable; provides mechanical stability to bone fragments during healing; material resorbs over time.

Clinical Evidence

No clinical data.

Technological Characteristics

Material: poly(L-lactide) (PLLA). Form factor: screw. Sterile. Bioabsorbable.

Indications for Use

Indicated for fixation of small bone fragments including apical fragments (radial head, patellar rim, navicular, metacarpal, metatarsal), osteochondral fragments (talar vault, femoral condyle), and cancellous fragments (talus).

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Submission Summary (Full Text)

{0}------------------------------------------------

K032098

OCT - 7 2003

# 510(k) Summary

| 510(k) Number: | Arthrex, Inc. |
|-----------------|-----------------------------------------|
| Company: | 2885 S. Horseshoe Dr., Naples, FL 34104 |
| Address: | [phone] |
| Telephone: | [phone] |
| Facsimile: | Ann Waterhouse |
| Contact: | |
| Trade Name: | Arthrex Bio-Compression Screw |
| Common Name: | Fastner, Fixation, Degradable |
| Classification: | Class II |

MAI

#### Description:

Product Code:

The Arthrex Bio-Compression Screw is manufactured using poly(L-lactide). These are offered sterile, in distinct sizes. Further description is contained in Tab 6.

#### Indications for Use:

The Arthrex Bio-Compression implant is a bioabsorbable polylactide (PLLA) screw intended to provide fixation of small bone fragments such as apical fragments, osteochondral fragments, and cancellous fragments. Specifically;

Apical Fragments: Radial Head, Patellar Rim, Navicular, Metacarpal and Metatarsal Osteochondral Fragments: Talar Vault, femoral condvle Cancellous Fragments: Talus

### Predicate Devices:

Please see Tab 7 for specific information concerning predicate devices.

#### Substantial Equivalence:

By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The difference between the Arthrex Bio-Compression Screw and the predicate devices with similar indications do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the material is well characterized and has been used in predicate devices with similar indications. The device, as designed, is as safe and effective as predicate devices.

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, represented by three curved lines, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 7 2003

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

Re: K032098

Trade/Device Name: Bio-Compression Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: July 7, 2003 Received: July 9, 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.

{2}------------------------------------------------

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 [phone]. 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 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 Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

## 510(k) Number (if known):

## Device Name:

## Indications for Use:

The Arthrex Bio-Compression Screw is a bioabsorbable polylactide (PLLA) screw intended to provide fixation of small bone fragments such as apical fragments, osteochondral fragments, and cancellous fragments. Specifically;

Apical Fragments: Radial Head, Patellar Rim, Navicular, Metacarpal and Metatarsal

Talar Vault, femoral condyle Osteochondral Fragments:

Talus Cancellous Fragments:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Option Format 3-10-98)

Mark N. Milken

Division of General, Restorative and Neurological Dey 510(k) Number