Cleared Traditional

ACTIFY? Unicondylar Knee System

K241260 · Globus Medical, Inc. · Orthopedic

Dec 2024

Decision

214d

Days

Class 2

Risk

About This 510(k) Submission

K241260 is an FDA 510(k) clearance for the ACTIFY? Unicondylar Knee System, a Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HSX), submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on December 6, 2024, 214 days after receiving the submission on May 6, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3520.

Submission Details

510(k) Number	K241260 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 06, 2024
Decision Date	December 06, 2024
Days to Decision	214 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HSX — Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3520