Omnifit Epf Dual Geometry Acetabular Cup

by Osteonics Corp.

510(k) K912654

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

14 closed

Documents

510(k) K912654↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK912654	Date16 Aug 1991Cleared	StatusActive

Recalls

14 recalls · FDA

14 recalls, same reason
- Terminated Z-1053-2011 FDA Unclassified (pre-2012) initiated 2 Aug 2010
- Terminated Z-1059-2011 FDA Unclassified (pre-2012) initiated 2 Aug 2010
- Terminated Z-1047-2011 FDA Unclassified (pre-2012) initiated 2 Aug 2010
- Terminated Z-1054-2011 FDA Unclassified (pre-2012) initiated 2 Aug 2010
- Terminated Z-1052-2011 FDA Unclassified (pre-2012) initiated 2 Aug 2010
- Terminated Z-1055-2011 FDA Unclassified (pre-2012) initiated 2 Aug 2010
- Terminated Z-1050-2011 FDA Unclassified (pre-2012) initiated 2 Aug 2010
- Terminated Z-1058-2011 FDA Unclassified (pre-2012) initiated 2 Aug 2010
- Terminated Z-1056-2011 FDA Unclassified (pre-2012) initiated 2 Aug 2010
- Terminated Z-1051-2011 FDA Unclassified (pre-2012) initiated 2 Aug 2010
- Terminated Z-1057-2011 FDA Unclassified (pre-2012) initiated 2 Aug 2010
- Terminated Z-1049-2011 FDA Unclassified (pre-2012) initiated 2 Aug 2010
- Terminated Z-1048-2011 FDA Unclassified (pre-2012) initiated 2 Aug 2010
- Terminated Z-1046-2011 FDA Unclassified (pre-2012) initiated 2 Aug 2010
Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K912654
FDA Product Code: MEH

Device Class: Class II
Regulation: 21 CFR Part 888.3353
Advisory Committee: Orthopedic
FDA Decision: SESE Substantially Equivalent

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