# K043440: Smith & Nephew, Inc. Revision Knee System

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 18, 2005 after 66 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: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K962137 (1996). 4 ancestors in all.
31 later devices descend from it; 11 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041106: Revision Knee System, Smith & Nephew, Inc. (2004) Summary page 1.
- K951987: Genesis II Total Knee System, Smith & Nephew Richards, Inc. (1995) Summary page 1.
- K953274: Genesis Porous Tibial Trays & Revision Knee System, Smith & Nephew Richards, Inc. (1996) Summary page 1.
- K962137: Genesis II Constrained System, Smith & Nephew Richards, Inc. (1996) 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 MOST System: named in the summary without a submission number

## Most influential descendants
- 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
- K151118: Smith and Nephew Legion Hinge Knee System (2015), 4 descendants of its own

## Recalls of this device
- Oct 2, 2024 · Class II · Z-0278-2025: Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
- Oct 2, 2024 · Class II · Z-0277-2025: Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
- May 19, 2021 · Class II · Z-1951-2021: The device components experienced a manufacturing process error that resulted in surface damage from product handling.
- Jan 15, 2018 · Class II · Z-2538-2019: The affected products were inadvertently packaged with an incorrect screw component.
- Jan 18, 2016 · Class II · Z-0816-2016: The package for catalog item, a LEGION Hemi Stepped Tibial Wedge, 5 MM Size 5-6 LT-LAT/ RT-MDL, should include both a screw-on hemi stepped tibial wedge and two tibial wedge screws to affix the wedge 
- Jan 22, 2009 · Not classified · Z-1819-2009: Products were mispackaged.
- Jan 22, 2009 · Not classified · Z-1820-2009: Products were mispackaged.

## Indications for use
The Revision Knee System Components are indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, 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/K043440
Methodology: https://510kreport.com/methodology