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Omnifit® 20° Series I Insert

by Howmedica Osteonics Corp., Dba Stryker Orthopaedics

510(k) K261624

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

Recall on shared 510(k) K261624; other models may be affected

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 NumberK261624 Date10 Jul 2026ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-3199-2026 FDA Class II initiated 30 Jul 2026 on shared 510(k) K261624
    • Ongoing Z-3201-2026 FDA Class II initiated 30 Jul 2026 on shared 510(k) K261624

    Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

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  • Withdrawn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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