# K241260: ACTIFY™ Unicondylar Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Dec 6, 2024 after 214 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: 13 generations back to K810258 (1981). 241 ancestors in all.
No later device cites it as a predicate yet.
0 of 241 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032824: Stelkast Unicondylar Knee System, Stelkast Company (2003) Summary page 5.
- K033363: Zimmer Unicompartmental Knee System, Zimmer, Inc. (2004) Summary page 5.
- 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, Smith & Nephew, Inc. (2023) Summary page 5.
- K071881: Triathlon PKR System, Howmedica Osteonics Corp. (2007) Summary page 5.
- K203099: Triathlon PKR System, Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics (2020) Summary page 5.

## Indications for use
The ACTIFY™ Unicondylar Knee System is indicated for unicompartmental knee replacement due to the following conditions: 1. Moderately disabling joint disease of the knee resulting from painful osteo- and/or post-traumatic arthritis, or avascular necrosis. 2. Revision of previous unsuccessful unicompartmental knee replacement or other procedure. 3. Alternative to tibial osteotomy in patients with unicompartmental osteoarthritis. 4. Previous tibial condyle or plateau fractures with loss of anatomy or function. 5. Varus or valgus deformities. These devices are indicated for cemented use only.

Source page: https://510kreport.com/device/K241260
Methodology: https://510kreport.com/methodology