# K972460: Osteonics Omnifit-C Cemented Hip Stem (Line Extension)

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Sep 25, 1997 after 86 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) Osteonics® Omnifit®-C Cemented Hip Stems: named in the summary without a submission number

## Indications for use
The Osteonics® Omnifit®-C Cemented Hip Stems are intended for single-use in patients requiring hemi-hip replacement, bi-polar hip replacement, or total hip replacement. The Osteonics® Omnifit®-C Cemented Hip Stems are intended for cemented applications. For use as a bipolar or hemi-hip replacement: Femoral head/neck fractures or non-unions. Aseptic necrosis of the femoral head. Osteo-, rtheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion. Other considerations Pathological conditions or age considerations that indicate a more conservative acetabular procedure and an avoidance of use of bone cement in the acetabulum. Salvage of a failed total hip arthroplasty. For use as a total hip replacement: Painful, disabling joint disease of the hip resulting from degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

Source page: https://510kreport.com/device/K972460
Methodology: https://510kreport.com/methodology