# K081111: Legion Hinge Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 23, 2008 after 96 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- 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: 3 generations back to K003504 (2001). 5 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023667: RT-Plus Solution & RT-Plus Modular Solution Knee, Plus Orthopedics (2002) Summary page 2.
- K013385: Nexgen Complete Knee Solution Rotatng Hinge Knee, Zimmer, Inc. (2002) Summary page 2.

## Cited in the summary but kept off the family tree
- K002757: Oncology Salvage System, Biomet, Inc. (2000). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K121393: Smith & Nephew, Inc. Total Knee System Instrumentation (2012), 5 descendants of its own
- K151118: Smith and Nephew Legion Hinge Knee System (2015), 4 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

## Recalls of this device
- Feb 1, 2018 · Class II · Z-1105-2018: The screws package with devices within lot 14AAP6352A were 5 MM instead of 10MM and are too short to be used with the Legion HK Distal Wedge Size 5.
- May 26, 2016 · Class II · Z-2092-2016: The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
- May 26, 2016 · Class II · Z-2093-2016: The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
- May 26, 2016 · Class II · Z-2090-2016: The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
- May 26, 2016 · Class II · Z-2091-2016: The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
- May 26, 2016 · Class II · Z-2094-2016: The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
- May 26, 2016 · Class II · Z-2095-2016: The surface inside of the femoral component, where cement is applied for adhesion, is below specification.

## Indications for use
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. 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. 5. Constrained and hinge 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 Legion Hinge Knee System is for Cemented Use Only.

Source page: https://510kreport.com/device/K081111
Methodology: https://510kreport.com/methodology