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Radial Head Implant

by Avanta Orthopaedics, Inc. 510(k)

Active United States

510(k) K002644

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK002644 Date20 Nov 2000ClearedStatusActive

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

21 recalls · FDA

  • 20 recalls, same reason

    • Terminated Z-2677-2018 FDA Class II initiated 24 Oct 2017 via K002644, on the same 510(k)
    • Terminated Z-2683-2018 FDA Class II initiated 24 Oct 2017 via K002644, on the same 510(k)
    • Terminated Z-2685-2018 FDA Class II initiated 24 Oct 2017 via K002644, on the same 510(k)
    • Terminated Z-2682-2018 FDA Class II initiated 24 Oct 2017 via K002644, on the same 510(k)
    • Terminated Z-2680-2018 FDA Class II initiated 24 Oct 2017 via K002644, on the same 510(k)
    • Terminated Z-2723-2018 FDA Class II initiated 24 Oct 2017 via K002644, on the same 510(k)
    • Terminated Z-2725-2018 FDA Class II initiated 24 Oct 2017 via K002644, on the same 510(k)
    • Terminated Z-2722-2018 FDA Class II initiated 24 Oct 2017 via K002644, on the same 510(k)
    • Terminated Z-2727-2018 FDA Class II initiated 24 Oct 2017 via K002644, on the same 510(k)
    • Terminated Z-2726-2018 FDA Class II initiated 24 Oct 2017 via K002644, on the same 510(k)
    • Terminated Z-2732-2018 FDA Class II initiated 24 Oct 2017 via K002644, on the same 510(k)
    • Terminated Z-2684-2018 FDA Class II initiated 24 Oct 2017 via K002644, on the same 510(k)
    • Terminated Z-2729-2018 FDA Class II initiated 24 Oct 2017 via K002644, on the same 510(k)
    • Terminated Z-2724-2018 FDA Class II initiated 24 Oct 2017 via K002644, on the same 510(k)
    • Terminated Z-2679-2018 FDA Class II initiated 24 Oct 2017 via K002644, on the same 510(k)
    • Terminated Z-2681-2018 FDA Class II initiated 24 Oct 2017 via K002644, on the same 510(k)
    • Terminated Z-2731-2018 FDA Class II initiated 24 Oct 2017 via K002644, on the same 510(k)
    • Terminated Z-2730-2018 FDA Class II initiated 24 Oct 2017 via K002644, on the same 510(k)
    • Terminated Z-2678-2018 FDA Class II initiated 24 Oct 2017 via K002644, on the same 510(k)
    • Terminated Z-2728-2018 FDA Class II initiated 24 Oct 2017 via K002644, 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.

    • Terminated Z-0098-2014 FDA Class II initiated 6 Sep 2013

    The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.

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

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