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ACTIFY Unicondylar Knee System

by Globus Medical, Inc.

510(k) K241260

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK241260 Date6 Dec 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HSX
Device class
Class II
Regulation
21 CFR Part 888.3520
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ACTIFY Unicondylar Knee System is a knee reconstruction device featuring an onlay design and semi-congruent tibial insert that allows the unaffected compartment to drive native knee kinematics. The system includes a range of femoral components, tibia trays, and tibial inserts to fit diverse anatomies. It is designed to enhance surgical efficiency with streamlined instruments that reduce inventory needs.

The ACTIFY Unicondylar Knee System is supplied by Globus Medical, Inc. and received FDA 510(k) clearance on December 6, 2024. It is classified under product code HSX and reviewed by the Orthopedic advisory committee. The system is designed for knee reconstruction procedures and accommodates various anatomies with its range of components.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ACTIFY Unicondylar Knee System designed for?

    The ACTIFY Unicondylar Knee System is designed for knee reconstruction procedures. It features an onlay design and semi-congruent tibial insert that allows the unaffected compartment to drive native knee kinematics, providing a solution for various anatomical needs.

  • What components are included in the ACTIFY Unicondylar Knee System?

    The system includes a range of femoral components, tibia trays, and tibial inserts to fit diverse anatomies. It is designed with streamlined instruments to enhance surgical efficiency and reduce inventory needs for healthcare providers.

  • What is the regulatory status of the ACTIFY Unicondylar Knee System?

    The ACTIFY Unicondylar Knee System received FDA 510(k) clearance on December 6, 2024. It is classified under product code HSX and was reviewed by the Orthopedic advisory committee, with a decision code of SESE indicating substantial equivalence.

  • How is the ACTIFY Unicondylar Knee System supplied?

    The ACTIFY Unicondylar Knee System is supplied by Globus Medical, Inc. from their Valley Forge Business Center location in Audubon, PA. The system is designed to accommodate various anatomies with its comprehensive range of components.