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Restoration Anatomic Shell

by Stryker Orthopaedics 2 variants

510(k) K151264

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

17 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 NumberK151264 Date10 Aug 2015ClearedStatusActive

Recalls

17 recalls · FDA

  • 16 recalls, same reason

    • Terminated Z-2092-2020 FDA Class II initiated 16 Apr 2020
    • Terminated Z-2088-2020 FDA Class II initiated 16 Apr 2020
    • Terminated Z-2091-2020 FDA Class II initiated 16 Apr 2020
    • Terminated Z-2099-2020 FDA Class II initiated 16 Apr 2020
    • Terminated Z-2086-2020 FDA Class II initiated 16 Apr 2020
    • Terminated Z-2084-2020 FDA Class II initiated 16 Apr 2020
    • Terminated Z-2098-2020 FDA Class II initiated 16 Apr 2020
    • Terminated Z-2095-2020 FDA Class II initiated 16 Apr 2020
    • Terminated Z-2087-2020 FDA Class II initiated 16 Apr 2020
    • Terminated Z-2085-2020 FDA Class II initiated 16 Apr 2020
    • Terminated Z-2094-2020 FDA Class II initiated 16 Apr 2020
    • Terminated Z-2096-2020 FDA Class II initiated 16 Apr 2020
    • Terminated Z-2089-2020 FDA Class II initiated 16 Apr 2020
    • Terminated Z-2097-2020 FDA Class II initiated 16 Apr 2020
    • Terminated Z-2093-2020 FDA Class II initiated 16 Apr 2020
    • Terminated Z-2090-2020 FDA Class II initiated 16 Apr 2020

    The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.

    • Terminated Z-2281-2016 FDA Class II initiated 3 Jun 2016

    Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method.

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  • Withdrawn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
LPH
Device Class
Class II
Regulation
21 CFR Part 888.3358
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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