# K912654: Omnifit Epf Dual Geometry Acetabular Cup

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Aug 16, 1991 after 60 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Aug 2, 2010 · Not classified · Z-1048-2011: Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification.
- Aug 2, 2010 · Not classified · Z-1049-2011: Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification.
- Aug 2, 2010 · Not classified · Z-1050-2011: Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification.
- Aug 2, 2010 · Not classified · Z-1052-2011: Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification.
- Aug 2, 2010 · Not classified · Z-1046-2011: Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification.
- Aug 2, 2010 · Not classified · Z-1047-2011: Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification.
- Aug 2, 2010 · Not classified · Z-1051-2011: Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification.
- Aug 2, 2010 · Not classified · Z-1053-2011: Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification.
- Aug 2, 2010 · Not classified · Z-1057-2011: Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification.
- Aug 2, 2010 · Not classified · Z-1059-2011: Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification.
- Aug 2, 2010 · Not classified · Z-1054-2011: Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification.
- Aug 2, 2010 · Not classified · Z-1055-2011: Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification.
- Aug 2, 2010 · Not classified · Z-1056-2011: Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification.
- Aug 2, 2010 · Not classified · Z-1058-2011: Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification.

Source page: https://510kreport.com/device/K912654
Methodology: https://510kreport.com/methodology