Skip to content

Modification to Radial Head Implant

by Avanta Orthopaedics, Inc. 510(k)

Active United States

510(k) K023604

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK023604 Date27 Nov 2002ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

18 recalls · FDA

  • 18 recalls, same reason

    • Terminated Z-2717-2018 FDA Class II initiated 24 Oct 2017 via K023604, on the same 510(k)
    • Terminated Z-2715-2018 FDA Class II initiated 24 Oct 2017 via K023604, on the same 510(k)
    • Terminated Z-2718-2018 FDA Class II initiated 24 Oct 2017 via K023604, on the same 510(k)
    • Terminated Z-2686-2018 FDA Class II initiated 24 Oct 2017 via K023604, on the same 510(k)
    • Terminated Z-2711-2018 FDA Class II initiated 24 Oct 2017
    • Terminated Z-2719-2018 FDA Class II initiated 24 Oct 2017 via K023604, on the same 510(k)
    • Terminated Z-2690-2018 FDA Class II initiated 24 Oct 2017 via K023604, on the same 510(k)
    • Terminated Z-2713-2018 FDA Class II initiated 24 Oct 2017
    • Terminated Z-2691-2018 FDA Class II initiated 24 Oct 2017 via K023604, on the same 510(k)
    • Terminated Z-2688-2018 FDA Class II initiated 24 Oct 2017 via K023604, on the same 510(k)
    • Terminated Z-2714-2018 FDA Class II initiated 24 Oct 2017 via K023604, on the same 510(k)
    • Terminated Z-2687-2018 FDA Class II initiated 24 Oct 2017 via K023604, on the same 510(k)
    • Terminated Z-2689-2018 FDA Class II initiated 24 Oct 2017 via K023604, on the same 510(k)
    • Terminated Z-2712-2018 FDA Class II initiated 24 Oct 2017
    • Terminated Z-2721-2018 FDA Class II initiated 24 Oct 2017 via K023604, on the same 510(k)
    • Terminated Z-2716-2018 FDA Class II initiated 24 Oct 2017 via K023604, on the same 510(k)
    • Terminated Z-2720-2018 FDA Class II initiated 24 Oct 2017 via K023604, on the same 510(k)
    • Terminated Z-2692-2018 FDA Class II initiated 24 Oct 2017 via K023604, on the same 510(k)

    Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
KWI
Device Class
Class II
Regulation
21 CFR Part 888.3170
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Avanta Orthopaedics, Inc.

See all devices from Avanta Orthopaedics, Inc. →