# K971497: Osteonics Anteverted Neck Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Jul 16, 1997 after 83 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- 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® AD Hip Stem Series: named in the summary without a submission number
- (no number) Zimmer® Anatomic Hip Prosthesis (including CP, BR, and LS versions): named in the summary without a submission number

## Indications for use
The Osteonics® Anteverted Neck Hip Stems are intended for single use in patients requiring either a bipolar hip replacement or a total hip replacement. The Osteonics® Anteverted Neck Hip Stems are intended to be implanted in a cementless application. These devices feature an Osteonics® C-Taper trunnion, and are therefore compatible with any Osteonics® component which features the mating Osteonics® C-Taper geometry. The Osteonics® Anteverted Neck Hip Stems, when used with any commercially available Osteonics® C-Taper femoral bearing head, may be used with any commercially available Osteonics® acetabular component. The indications for the use of the Osteonics® Anteverted Neck Hip Stems, in keeping with those of other legally marketed Class II hip stems, are as follows: For use as a Bipolar Hip Replacement: Femoral head/neck fractures or non-unions. Aseptic necrosis of the femoral head. Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion. Other Considerations: Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum. 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/K971497
Methodology: https://510kreport.com/methodology