# K963671: Osteonics Flanged Polyethylene Acetabular Cup

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Feb 3, 1997 after 143 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® All Polyethylene Acetabular Cups: named in the summary without a submission number
- (no number) DePuy Ogee® Acetabular Cups: named in the summary without a submission number

## Indications for use
The indications for the use of this acetabular component, in keeping with those of other legally marketed Osteonics acetabular components, are as follows: 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. 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/K963671
Methodology: https://510kreport.com/methodology