# K160738: ZUK Select Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 15, 2016 after 90 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: 10 generations back to K810258 (1981). 75 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122529: Zimmer Unicompartmental Knee System Vivacit-E Articular Surface, Zimmer, Inc. (2012) Summary page 8.
- K093056: Smith & Nephew, Inc. Journey Select Knee System, Smith & Nephew, Inc. (2009) Summary page 8.
- K081351: Modification to Journey Unicondylar Femoral Implant, Smith & Nephew, Inc. (2008) Summary page 8.
- K051086: Smith & Nephew Patello-Femoral Implant, Smith & Nephew, Inc. (2005) Summary page 8.
- K033363: Zimmer Unicompartmental Knee System, Zimmer, Inc. (2004) Summary page 8.

## Most influential descendants
- K190085: Journey II Unicompartmental Knee System (2019), 7 descendants of its own
- 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

## Indications for use
The ZUK Unicompartmental Knee System is indicated for patients with: -Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. -Previous tibial condyle or plateau fractures with loss of anatomy or function. -Varus or valgus deformities. -Revision of previous arthroplasty procedures. -These devices are indicated for cemented use only. -The ZUK Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. Indications for JOURNEY Unicompartmental Knee Replacement: 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; • 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. HA coated unicompartmental knee implants are available outside the US for use without bone cement. Indications for JOURNEY Patello-Femoral Replacement: • Degenerative arthritis in the distal femur and patella; • A history of patellar dislocation or patellar fracture; and • Failed previous surgery (arthroplasty, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists. The Smith & Nephew patello-femoral implants are intended for implantation with bone cement. Indications for Combined Unicompartmental and Patello-Femoral Replacement: • Post-traumatic arthritis; • Degenerative arthritis; and • Failed osteotomies and unicompartmental replacement These indications will be used for the combined unicompartmental and patello-femoral implant device, whereby a single condyle and patello-femoral regions have been affected by one or more of these conditions. Combined Unicompartmental and Patello-Femoral implants are intended for implantation with bone cement.

Source page: https://510kreport.com/device/K160738
Methodology: https://510kreport.com/methodology