# K191211: JOURNEY II Unicompartmental Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 25, 2019 after 80 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: 12 generations back to K810258 (1981). 102 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 104 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 4.
- K160738: ZUK Select Knee System, Smith & Nephew, Inc. (2016) Summary page 4.

## Most influential descendants
- K222653: JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System (2022), 0 descendants of its own

## Indications for use
Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following: • Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis. • Correction of functional deformity. • Revision of previous arthroplasty procedures. • Treatment of fractures that are unmanageable using other techniques. Unicompartmental knee implants are single use only and are intended for implantation only with bone cement

Source page: https://510kreport.com/device/K191211
Methodology: https://510kreport.com/methodology