# K962137: Genesis II Constrained System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Richards, Inc.
- Decided: Aug 2, 1996 after 60 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
93 later devices descend from it; 6 cite it directly.
0 of 94 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) Genesis Constrained Knee System: named in the summary without a submission number
- (no number) Genesis I Knee System: named in the summary without a submission number
- (no number) Genesis I P/S Knee Systems: named in the summary without a submission number
- (no number) Insall/Burstein Constrained Condylar Knee: named in the summary without a submission number
- (no number) P.F.C. Modular Knee System: named in the summary without a submission number
- (no number) Omnifit Total Knee System: named in the summary without a submission number
- (no number) Coordinate Revision Knee System: named in the summary without a submission number

## Most influential descendants
- K071071: Crosslinked Polyethylene Articular Inserts (2007), 66 descendants of its own
- K111711: Journey II BCS Knee System (2011), 40 descendants of its own
- K121443: Journey II CR Knee System (2012), 37 descendants of its own
- K041106: Revision Knee System (2004), 32 descendants of its own
- K043440: Smith & Nephew, Inc. Revision Knee System (2005), 31 descendants of its own

## Recalls of this device
- Sep 21, 2020 · Class II · Z-0118-2021: The anterior locking detail does not meet its design specifications.

## Indications for use
The Genesis II 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. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. The Genesis Il 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 I1 Constrained System is indicated for use with cement and is a single use device.

Source page: https://510kreport.com/device/K962137
Methodology: https://510kreport.com/methodology