# K222653: JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Smith+Nephew, Inc.
- Decided: Oct 28, 2022 after 57 days
- Product code: NJD (Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3535
- 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). 127 ancestors in all.
No later device cites it as a predicate yet.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190439: Engage™ Partial Knee System, Engage Uni, LLC (2019) Summary page 6.
- K190085: Journey II Unicompartmental Knee System, Smith & Nephew, Inc. (2019) Summary page 6.
- K191211: JOURNEY II Unicompartmental Knee System, Smith & Nephew, Inc. (2019) Summary page 6.

## Indications for use
Indications for JOURNEY II Unicompartmental Knee System: 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 intended for implantation only with bone cement. Indications for ENGAGE™ Partial Knee System: The ENGAGE™ Partial Knee System is intended for medial unicompartmental knee arthroplasty to treat one or more of the following conditions: - Moderately disabling joint disease of the knee resulting from painful osteo- or post-traumatic arthritis. - Revision of previous unsuccessful surgical procedures including prior unicompartmental knee arthroplasty - As an alternative to tibial osteotomy in patients with Unicompartmental osteoarthritis. The femoral component and tibial tray are intended for cementless or cemented fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. When the tibial tray is implanted without the use of bone cement, the tibial anchor should be used. When the tibial tray is implanted with bone cement, the tibial anchor should not be used.

Source page: https://510kreport.com/device/K222653
Methodology: https://510kreport.com/methodology