# K952271: Genesis Constrained System (GCS)

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Richards, Inc.
- Decided: Sep 8, 1995 after 116 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.
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) Genesis Posterior Stabilized Knee System - Smith & Nephew Richards: named in the summary without a submission number
- (no number) Insall/Burstein Constrained Condylar Knee - Zimmer: named in the summary without a submission number
- (no number) P.1° CC. Modular Knee System - Johnson & Johnson: named in the summary without a submission number
- (no number) Kinemax Plus Total Knee System - Howmedica: named in the summary without a submission number
- (no number) Omnifit Total Knee System - Osteonics: named in the summary without a submission number
- (no number) $-ROM Modular Knee System - Joint Medical Product: named in the summary without a submission number
- (no number) Coordinate Revision Knee System - Depuy: named in the summary without a submission number
- (no number) Ad-antim Total Knee System - Wright Medical Technology: named in the summary without a submission number

## Indications for use
The Genesis Constrained System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. The Genesis Constrained System is designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent. The Genesis Constrained System is indicated for use with cement and is a single use device.

Source page: https://510kreport.com/device/K952271
Methodology: https://510kreport.com/methodology