# K220896: Legion Inserts with JRNY Lock

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Apr 26, 2022 after 29 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: 8 generations back to K951987 (1995). 23 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071071: Crosslinked Polyethylene Articular Inserts, Smith & Nephew, Inc. (2007) Summary page 5.
- K962137: Genesis II Constrained System, Smith & Nephew Richards, Inc. (1996) Summary page 5.
- K200407: LEGION Inserts with JRNY Lock, Smith & Nephew, Inc. (2020) Summary page 5.

## Most influential descendants
- K250677: LEGION Total Knee System (2025), 0 descendants of its own

## 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. 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.c. medial collateral and/or lateral collateral ligament) are incompetent. The Smith & Nephew LEGION Inserts with JRNY Lock are single use devices.

Source page: https://510kreport.com/device/K220896
Methodology: https://510kreport.com/methodology