# K200407: LEGION Inserts with JRNY Lock

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 13, 2020 after 23 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: 7 generations back to K951987 (1995). 22 ancestors in all.
2 later devices descend from it; 2 cite 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 4.
- K121443: Journey II CR Knee System, Smith & Nephew, Inc. (2012) Summary page 4.
- K111711: Journey II BCS Knee System, Smith & Nephew, Inc. (2011) Summary page 4.

## Most influential descendants
- K220896: Legion Inserts with JRNY Lock (2022), 1 descendant of its own
- 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. The Smith & Nephew Legion Inserts with JRNY Lock are single use devices.

Source page: https://510kreport.com/device/K200407
Methodology: https://510kreport.com/methodology