# K190085: Journey II Unicompartmental Knee System

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 11, 2019 after 25 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K810258 (1981). 101 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152315: JOURNEY II Uni Tibial Base and Insert, Smith & Nephew, Inc. (2015) Summary page 4.
- K102069: Journey Unicondylar Tibial Baseplates, Smith & Nephew, Inc. (2010) Summary page 4.
- K160738: ZUK Select Knee System, Smith & Nephew, Inc. (2016) Summary page 4.

## Most influential descendants
- 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 (2023), 3 descendants of its own
- K191211: JOURNEY II Unicompartmental Knee System (2019), 1 descendant of its own
- K261462: LANDMARK Total Knee System (2026), 0 descendants of its own
- K241260: ACTIFY™ Unicondylar Knee System (2024), 0 descendants of its own
- K242711: JOURNEY II Unicompartmental Knee System (JOURNEY II UK) (2024), 0 descendants of its own

## Recalls of this device
- Mar 27, 2023 · Class II · Z-1393-2023: A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Siz
- Jan 28, 2020 · Class II · Z-2133-2020: The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.
- Jan 28, 2020 · Class II · Z-2132-2020: The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.

## 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 procedures where other treatments or devices have failed; and • 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/K190085
Methodology: https://510kreport.com/methodology