# K060742: Legion Cobalt Chrome Revision Knee System

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: May 3, 2006 after 44 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K962137 (1996). 5 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043440: Smith & Nephew, Inc. Revision Knee System, Smith & Nephew, Inc. (2005) Summary page 1.
- K041106: Revision Knee System, Smith & Nephew, Inc. (2004) Summary page 1.
- (no number) Zimmer Legacy Constrained Condylar Knee (L-CCK): named in the summary without a submission number
- (no number) Biomet Oncology Salvage System (OSS): named in the summary without a submission number
- (no number) Sulzer Orthopedics MOSTTM System: named in the summary without a submission number

## Most influential descendants
- K121393: Smith & Nephew, Inc. Total Knee System Instrumentation (2012), 5 descendants of its own
- K230653: Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates (2023), 3 descendants of its own
- K123159: Smith & Newphew, Inc. Disposable Knee Instruments (2013), 2 descendants of its own
- K173331: JOURNEY II XR Knee Instruments (2017), 1 descendant of its own
- K261462: LANDMARK Total Knee System (2026), 0 descendants of its own

## Recalls of this device
- Nov 4, 2014 · Class II · Z-0589-2015: The stem taper on this device is undersized; the gauge point is not deep enough.
- Nov 4, 2014 · Class II · Z-0591-2015: The stem taper on this device is undersized; the gauge point is not deep enough.
- Nov 4, 2014 · Class II · Z-0590-2015: The stem taper on this device is undersized; the gauge point is not deep enough.

## Indications for use
Revision Knee System components are indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthdtis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. The constrained knee systems are 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 Revision Knee components are for single use only and are intended for implantation with bone cement.

Source page: https://510kreport.com/device/K060742
Methodology: https://510kreport.com/methodology