Cleared Traditional

K241260 - ACTIFY™ Unicondylar Knee System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241260 · Globus Medical, Inc. · Orthopedic device
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Dec 2024
Decision
214d
Days
Class 2
Risk

K241260 is an FDA 510(k) clearance for the ACTIFY™ Unicondylar Knee System. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on December 6, 2024 after a review of 214 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3520 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Globus Medical, Inc. devices

Submission Details

510(k) Number K241260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 122d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3520
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

All 113
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K241260.
Tahoe Unicondylar Knee System with TiNbN Overcoat
K260796 · Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics · Apr 2026
Cambridge Partial Knee
K251771 · Signature Orthopaedics Pty, Ltd. · Dec 2025
Persona Partial Knee
K251834 · Zimmer Biomet · Aug 2025
MOTO Partial Knee System Extension
K251618 · Medacta International S.A. · Jul 2025
Arthrex iBalance Partial Knee System
K251453 · Arthrex, Inc. · Jul 2025
JOURNEY II Unicompartmental Knee System (JOURNEY II UK)
K242711 · Smith & Nephew, Inc. · Oct 2024