# K262251: ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)

- Pathway: 510(k) (Special)
- Applicant: Globus Medical, Inc.
- Decided: Jul 31, 2026 after 30 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K810258 (1981). 179 ancestors in all.
No later device cites it as a predicate yet.
0 of 180 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240669: ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System, Globus Medical, Inc. (2024) Summary page 5.
- K063211: Proven Knee System High Flexion Tibial Insert, Stelkast Company (2007) Summary page 5.
- K122883: Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee System, Stelkast Company (2013) Summary page 5.
- K162222: GENflex2 Total Knee System, Stelkast, Inc. (2016) Summary page 5.
- K173875: GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert, Stelkast, Inc. (2018) Summary page 5.
- K211609: ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert, Depuy Ireland UC (2021) Summary page 5.

## Indications for use
ACTIFY™ Total Knee System and ACTIFY™ 3D Total Knee System are indicated for single use only in skeletally mature individuals undergoing reconstruction of severely disabled and/or very painful joints. ACTIFY™ Total Knee System and ACTIFY™ 3D Total Knee System are indicated for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or posttraumatic degenerative problems, and revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. ACTIFY™ Total Knee System is indicated for cemented use only, except for the porous femoral component which is indicated for both cemented and uncemented use. ACTIFY™ 3D Total Knee System is indicated for cemented and uncemented use.

Source page: https://510kreport.com/device/K262251
Methodology: https://510kreport.com/methodology