# K112941: Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral Components

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Dec 20, 2011 after 77 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: 6 generations back to K951987 (1995). 11 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951987: Genesis II Total Knee System, Smith & Nephew Richards, Inc. (1995) Summary page 2.
- K962557: Genesis II Zirconium  Femoral Component/Profix Zirconium Femoral Component, Smith & Nephew Richards, Inc. (1996) Summary page 2.
- K093746: Verilast Wear Claims for the Legion Primary Knee System, Smith & Nephew, Inc. (2010) Summary page 2.

## Most influential descendants
- K142807: ANTHEM PS Total Knee System (2014), 7 descendants of its own
- K170648: ANTHEM CR Total Knee System (2017), 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
- K261462: LANDMARK Total Knee System (2026), 0 descendants of its own
- K241260: ACTIFY™ Unicondylar Knee System (2024), 0 descendants of its own

## Recalls of this device
- Oct 2, 2024 · Class II · Z-0282-2025: Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.
- Aug 31, 2023 · Class II · Z-2621-2023: The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the pr
- Apr 19, 2022 · Class II · Z-1099-2022: It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.

## Indications for use
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement. 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. Smith & Nephew, Inc. Legion Narrow Oxinium CR and P/S Femoral Components are indicated for use only with cement and are single use only devices.

Source page: https://510kreport.com/device/K112941
Methodology: https://510kreport.com/methodology