# K041106: Revision Knee System

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 1, 2004 after 64 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
Longest line of descent: 1 generation back to K962137 (1996). 1 ancestor in all.
32 later devices descend from it; 5 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962137: Genesis II Constrained System, Smith & Nephew Richards, Inc. (1996) Summary page 1.
- (no number) Genesis II Total Knee System: named in the summary without a submission number

## Most influential descendants
- K043440: Smith & Nephew, Inc. Revision Knee System (2005), 31 descendants of its own
- K060742: Legion Cobalt Chrome Revision Knee System (2006), 10 descendants of its own
- K121393: Smith & Nephew, Inc. Total Knee System Instrumentation (2012), 5 descendants of its own
- K053390: Columbus (CR) Total Knee System (2006), 5 descendants of its own
- K180334: LEGION Knee System (2018), 4 descendants of its own

## Recalls of this device
- Sep 14, 2017 · Class II · Z-0092-2018: The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.

## Indications for use
The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthritis; degenerative arthritis; and failed osteotomies, hemiarthroplasties; unicompartmental replacement; or total knee arthroplasties. The components are designed for use 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 Revision Knee Components are for single use only and are intended for implantation with bone cement.

Source page: https://510kreport.com/device/K041106
Methodology: https://510kreport.com/methodology