# K250677: LEGION Total Knee System

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Apr 2, 2025 after 27 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: 9 generations back to K951987 (1995). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200407: LEGION Inserts with JRNY Lock, Smith & Nephew, Inc. (2020) Summary page 5.
- K211671: Journey II Mid-Level Tibial Inserts, Smith & Nephew, Inc. (2021) Summary page 5.
- K220896: Legion Inserts with JRNY Lock, Smith & Nephew, Inc. (2022) Summary page 5.

## Indications for use
• Rheumatoid arthritis; • Post-traumatic arthritis, osteoarthritis, or degenerative arthritis; • Posterior stabilized and constrained knee systems are also indicated for the treatment of 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. • 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 incompetent.

Source page: https://510kreport.com/device/K250677
Methodology: https://510kreport.com/methodology