# K120698: Genesis II PS Non-Modular Femoral Component

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: May 18, 2012 after 72 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 K951987 (1995). 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)
- K951987: Genesis II Total Knee System, Smith & Nephew Richards, Inc. (1995) Summary page 1.

## Indications for use
The Genesis II PS Non-modular and CR Non-modular with cement pocket Femoral Components are indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. The Genesis II PS Non-modular and CR Non-modular with cement pocket Femoral Components are indicated for use only with cement and are single use devices.

Source page: https://510kreport.com/device/K120698
Methodology: https://510kreport.com/methodology