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Biomet Proximal Humerus Plating System

by Biomet Manufacturing

510(k) K143697

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

18 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 NumberK143697 Date30 Mar 2015ClearedStatusActive

Recalls

18 recalls · FDA

  • 18 recalls, same reason

    • Terminated Z-2313-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2306-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2321-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2312-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2315-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2309-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2316-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2318-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2307-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2319-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2320-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2324-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2314-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2323-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2305-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2311-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2317-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2322-2020 FDA Class II initiated 14 May 2020

    Distributed to the field without having completed design history files or design transfer activities

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  • Withdrawn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
HRS
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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