# K242711: JOURNEY II Unicompartmental Knee System (JOURNEY II UK)

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 30, 2024 after 51 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K810258 (1981). 212 ancestors in all.
No later device cites it as a predicate yet.
0 of 212 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190085: Journey II Unicompartmental Knee System, Smith & Nephew, Inc. (2019) Summary page 5.
- 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, Smith & Nephew, Inc. (2023) Summary page 5.

## Indications for use
Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following: Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; and Partial revisions to replace the tibial insert of the previously implanted JOURNEY II UK knee in the case the femoral and tibial components are well-fixed. Unicompartmental knee implants are single use only and are intended for implantation only with bone cement.

Source page: https://510kreport.com/device/K242711
Methodology: https://510kreport.com/methodology