# K983870: Osteonics Restoration HA Hip Stems

- Pathway: 510(k) (Special)
- Applicant: Osteonics Corp.
- Decided: Dec 2, 1998 after 30 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® Restoration HA Hip Stems: named in the summary without a submission number

## Indications for use
The indications for the use of the Osteonics® Restoration HA Stems, in keeping with those of other legally marketed Osteonics femoral components, 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. Salvage of 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. Additional Indication for Osteonics Head/Neck Stems: Clinical circumstances which require an altered femoral resection level due to a proximal fracture, bone loss or calcar lysis.

Source page: https://510kreport.com/device/K983870
Methodology: https://510kreport.com/methodology