# K980766: Osteonics Anteverted Neck HA Hip Stems

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: May 27, 1998 after 89 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: 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 Anteverted Neck Hip Stems: named in the summary without a submission number
- (no number) Osteonics® Secur-Fit HA Plus Hip Stem Series: named in the summary without a submission number

## Indications for use
The Osteonics® Anteverted Neck HA Hip Stems are intended for single use in patients requiring either bipolar, hemi- or total hip replacement. The Osteonics® Anteverted Neck HA 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 HA 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 HA Hip Stems, in keeping with those of other legally marketed Class II hip stems, are as follows: For use as a Bipolar/Hemi- Hip Replacement: . Femoral head/neck fractures or-non-unions. . Aseptic necrosis of the femoral head. . Osteo-, theumatoid, 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 ar 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/K980766
Methodology: https://510kreport.com/methodology