# K963959: Osteonics Modular Acetabular Cup (HA-Coated Version)

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Dec 19, 1996 after 78 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® Secur-Fit™ HA PSL® Shells: named in the summary without a submission number
- (no number) Osteonics® Restoration GAP Acetabular Cups: named in the summary without a submission number
- (no number) Osteonics® Omnifit® Cup Inserts: named in the summary without a submission number

## Indications for use
Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatmd 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. Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Source page: https://510kreport.com/device/K963959
Methodology: https://510kreport.com/methodology