# K960302: Consensus Acetabular Shell, All Uhmwpe

- Pathway: 510(k) (Traditional)
- Applicant: U.S. Medical Products, Inc.
- Decided: Apr 1, 1996 after 70 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
Longest line of descent: 1 generation back to K912426 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912426: Uhmwp Acetabular Component, Howmedica Corp. (1991) Summary page 1.

## Indications for use
The CONSENSUS® Acetabular Shell, All UHMWPE is indicated for use in; 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis and avascular necrosis with a non-acute fracture of the femoral neck. Osteoarthrosis involving femoral and acetabular articular surfaces. Avascular osteonecrosis and/or non-union of acute femoral neck fractures. Fracture-dislocation of the hip. Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists.

Source page: https://510kreport.com/device/K960302
Methodology: https://510kreport.com/methodology