# K963946: Osteonics Modular Acetabular Cup (Microstructured Version)

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Jan 27, 1997 after 117 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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® PSL® MicroStructured® 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

## Most influential descendants
- K992359: MRS-Titan (2000), 0 descendants of its own

## Indications for use
The indications for the use of the Osteonics® Modular Acetabular Cup, 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/K963946
Methodology: https://510kreport.com/methodology