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Arthrex Interference Screw-Rounded Head Screws, Full Threaded Screws, Sheathed Cannulated Interference Screws

by Arthrex, Inc.

510(k) K052607

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 NumberK052607 Date7 Nov 2005ClearedStatusActive

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  • Withdrawn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, 24 Sep 2026

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

Arthrex Interference Screw-Rounded Head Screws, Full Threaded Screws, Sheathed Cannulated Interference Screws are orthopedic devices used for fixation of soft tissue or bone in surgical procedures. These interference screws are designed to provide secure anchoring in bone tunnels, commonly employed in ligament and tendon reconstructions such as anterior cruciate ligament (ACL) repairs.

The device is supplied non-sterile and is intended for single-use. It received FDA 510(k) clearance under K052607 on November 7, 2005, and is classified under product code HWC. The device is manufactured by Arthrex, Inc. and is available in various sizes as specified in the product line, though exact dimensions are not detailed in the provided data.

Other devices from Arthrex, Inc.

See all devices from Arthrex, Inc. →

Questions

AI-generated answers, 24 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 Interference Screw-Rounded Head Screws, Full Threaded Screws, Sheathed Cannulated Interference Screws used for?

    These interference screws are orthopedic devices designed to provide secure anchoring in bone tunnels during surgical procedures, commonly employed in ligament and tendon reconstructions such as anterior cruciate ligament (ACL) repairs, where fixation of soft tissue or bone is required.

  • How is the Arthrex Interference Screw supplied and is it reusable?

    The device is supplied non-sterile and is intended for single-use only, meaning it should not be reprocessed or reused after a surgical procedure to ensure patient safety and device integrity.

  • What regulatory pathway was used for the Arthrex Interference Screw and when was it cleared?

    The device received FDA 510(k) clearance under submission number K052607 on November 7, 2005, based on a determination of substantial equivalence to a legally marketed predicate device.

  • What sizes or models are available for the Arthrex Interference Screw?

    The device is available in various sizes as specified in the Arthrex product line, though exact dimensions are not detailed in the provided data; users should consult the manufacturer’s labeling or catalog for specific size options.