# K190439: Engage™ Partial Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Engage Uni, LLC
- Decided: Nov 21, 2019 after 269 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K943462 (1994). 39 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133811: Restoris Porous Partial Knee System, Mako Surgical Corp. (2014) Summary page 4.

## Cited in the summary but kept off the family tree
- K033810: Natural-Knee II Unicompartmental Knee System, Centerpulse Orthopedics, Inc. (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K163700: Bodycad Unicompartmental Knee System, Bodycad Laboratories, Inc. (2017). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

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

## Recalls of this device
- May 2, 2023 · Class II · Z-1671-2023: Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the
- May 2, 2023 · Class II · Z-1672-2023: Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the
- May 2, 2023 · Class II · Z-1670-2023: Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the
- May 2, 2023 · Class II · Z-1673-2023: Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the

## Indications for use
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/K190439
Methodology: https://510kreport.com/methodology