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Resorbable Interference Screw

by Arthrotek, Inc.

510(k) K041274

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

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 NumberK041274 Date28 Jul 2004ClearedStatusActive

Recalls

5 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-1738-2018 FDA Class II initiated 28 Mar 2018
    • Terminated Z-1737-2018 FDA Class II initiated 28 Mar 2018
    • Terminated Z-1735-2018 FDA Class II initiated 28 Mar 2018
    • Terminated Z-1736-2018 FDA Class II initiated 28 Mar 2018

    Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.

    • Terminated Z-1944-2015 FDA Class II initiated 3 Jun 2015

    Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads Interference Screw 9x35mm Full Thread. If the incorrect screw is used various failures may occur which may ultimately lead to revision surgery or a delay in surgery.

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  • Withdrawn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

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