# K952943: Consensus All Poly Tibia

- Pathway: 510(k) (Traditional)
- Applicant: U.S. Medical Products, Inc.
- Decided: Apr 1, 1996 after 280 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- 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 K910563 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922048: Duracon All Plastic Tibial Component, Howmedica Corp. (1992) Summary page 1.
- K923443: Natural-Knee All-Poly Tibia, Intermedics Orthopedics (1993) Summary page 1.
- K910563: P.F.C.(R) Modular Knee Syst, Stab All-Plast Tibial, Johnson & Johnson Orthopaedics, Inc. (1991) Summary page 1.

## Indications for use
The Consensus® All Poly Tibia is indicated for use in: 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis. 2. Failed osteotomy or unicompartmental replacements 3. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.

Source page: https://510kreport.com/device/K952943
Methodology: https://510kreport.com/methodology