Cleared Traditional

K251161 - ANTHEM Fracture System

K251161 is the FDA 510(k) clearance for ANTHEM Fracture System by Globus Medical, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K251161 · Globus Medical, Inc. · Orthopedic device
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Aug 2025
Decision
125d
Days
Class 2
Risk

K251161 is an FDA 510(k) clearance for the ANTHEM® Fracture System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on August 18, 2025 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 K251161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2025
Decision Date August 18, 2025
Days to Decision 125 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
3d slower than avg
Panel avg: 122d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 885
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K251161.
Treace Medical Concepts (TMC) Implant Fixation System
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The Acumed Wrist Fixation System - 2.4mm Screws
K252356 · Acumed, LLC · Aug 2025
Distal Xtremities System
K252061 · TriMed, Inc. · Aug 2025
OsteoCentric® UnifiMI® TCS Plating System
K251913 · OsteoCentric Technologies · Aug 2025
KLS Martin Ixos System
K250620 · KLS-Martin L.P. · Aug 2025
Tyber Medical Distal Radius Plating System
K251361 · Tyber Medical, LLC · Jul 2025