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Trident® II Acetabular System

by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

510(k) K171768

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

12 ongoing

This device is named in the recall

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 NumberK171768 Date2 Oct 2017ClearedStatusActive

Recalls

12 recalls · 12 ongoing · FDA

  • 12 recalls, same reason

    • Ongoing Z-1622-2024 FDA Class II initiated 27 Feb 2024
    • Ongoing Z-1632-2024 FDA Class II initiated 27 Feb 2024
    • Ongoing Z-1628-2024 FDA Class II initiated 27 Feb 2024
    • Ongoing Z-1623-2024 FDA Class II initiated 27 Feb 2024
    • Ongoing Z-1626-2024 FDA Class II initiated 27 Feb 2024
    • Ongoing Z-1629-2024 FDA Class II initiated 27 Feb 2024
    • Ongoing Z-1625-2024 FDA Class II initiated 27 Feb 2024
    • Ongoing Z-1621-2024 FDA Class II initiated 27 Feb 2024
    • Ongoing Z-1631-2024 FDA Class II initiated 27 Feb 2024
    • Ongoing Z-1624-2024 FDA Class II initiated 27 Feb 2024
    • Ongoing Z-1630-2024 FDA Class II initiated 27 Feb 2024
    • Ongoing Z-1627-2024 FDA Class II initiated 27 Feb 2024 on shared 510(k) K171768

    The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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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