# K093746: Verilast Wear Claims for the Legion Primary Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Apr 14, 2010 after 131 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K951987 (1995). 10 ancestors in all.
29 later devices descend from it; 3 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962557: Genesis II Zirconium  Femoral Component/Profix Zirconium Femoral Component, Smith & Nephew Richards, Inc. (1996) Summary page 1.
- K071071: Crosslinked Polyethylene Articular Inserts, Smith & Nephew, Inc. (2007) Summary page 1.

## Most influential descendants
- K142787: Zimmer Persona Personalized Knee System (2014), 16 descendants of its own
- K172524: Zimmer Persona Personalized Knee System (2018), 15 descendants of its own
- K112941: Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral Components (2011), 8 descendants of its own
- K142807: ANTHEM PS Total Knee System (2014), 7 descendants of its own
- K173890: GMK Sphere - Kinematic Alignment (2018), 6 descendants of its own

## Indications for use
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; 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 absent or incompetent and the collateral ligaments remain intact. Smith & Nephew. Inc. Legion Primary Knee components are indicated for use only with cement and are single use devices.

Source page: https://510kreport.com/device/K093746
Methodology: https://510kreport.com/methodology