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Arthrex Bio-Compression Screw

by Arthrex, Inc.

510(k) K060478

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK060478 Date19 May 2006ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HWC
Device class
Class II
Regulation
21 CFR Part 888.3040
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Arthrex Bio-Compression Screw is a 3.0 mm device for fracture and osteotomy fixation in periarticular applications, offering interfragmentary compression with a headless profile to promote healing. It is produced from solid enhanced PLLA and designed for excellent thread-to-bone contact.

This screw is versatile for treating a broad range of indications in both lower and upper extremities, featuring a stepped pitch and taper design that draws two fragments together using straightforward instrumentation for drilling and tapping. Made of solid enhanced PLLA material, the Bio-Compression Screw absorbs over time without losing strength during insertion or through the healing process.

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Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Arthrex Bio-Compression Screw used for?

    The Arthrex Bio-Compression Screw is designed for fracture and osteotomy fixation in periarticular applications, providing interfragmentary compression to promote healing in both upper and lower extremities.

  • What material is the Bio-Compression Screw made of?

    The screw is produced from solid enhanced PLLA material, which absorbs over time without losing strength during insertion or throughout the healing process, ensuring excellent thread-to-bone contact.

  • Is the Bio-Compression Screw reusable or single-use?

    The device is designed for single-use applications only, as it is made of biodegradable material that absorbs over time and cannot be resterilized for reuse.

  • What sizes and models are available for the Bio-Compression Screw?

    The Arthrex Bio-Compression Screw is available as a 3.0mm device with a headless profile, featuring a stepped pitch and taper design that draws two fragments together using straightforward instrumentation for drilling and tapping.

  • What is the regulatory status of the Bio-Compression Screw?

    The Arthrex Bio-Compression Screw has received FDA 510(k) clearance with the K number K060478, classified under product code HWC, and was determined to be substantially equivalent to predicate devices.