Cleared Traditional

K251161 - ANTHEM® Fracture System

K251161 is an FDA 510(k) clearance for ANTHEM Fracture System, manufactured by Globus Medical, Inc.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K251161

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.

HRS Device Classification - Class 2, Special Controls

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 1213
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
K251135 · Treace Medical Concepts · Aug 2025
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