# K946088: Genesis Posterior Stabilized (P/S) Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Richards, Inc.
- Decided: Aug 8, 1995 after 238 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
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) Smith & Nephew Richards' RMC Posterior Stabilized Knee System: named in the summary without a submission number
- (no number) Zimmer's Insall/Burstein Posterior Stabilized Knee System: named in the summary without a submission number
- (no number) Johnson & Johnson's P.F.C. Modular Knee System: named in the summary without a submission number
- (no number) Howmedica's Kinemax Plus Total Knee System: named in the summary without a submission number
- (no number) Osteonics' Omnifit Total Knee System: named in the summary without a submission number
- (no number) Joint Medical Product's S-ROM Modular Knee System: named in the summary without a submission number
- (no number) Dow Corning Wright's Whiteside Ortholoc II Modular Knee System: named in the summary without a submission number
- (no number) Biomet's AGC Total Knee System: named in the summary without a submission number
- (no number) Depuy's Coordinate Knee System: named in the summary without a submission number

## Most influential descendants
- K140222: Saiph Knee System (2014), 0 descendants of its own

## Indications for use
The Genesis Posterior Stabilized (P/S) Knee System is indicated for restoring a knee that has been damaged by rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, failed osteotomies or hemi-arthroplasties where the anterior and posterior cruciate ligaments are absent or incompetent. The Genesis P/S Knee System is indicated for use with cement and is a single use device.

Source page: https://510kreport.com/device/K946088
Methodology: https://510kreport.com/methodology