Cleared Traditional

ANTHEM? Fracture System

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

About This 510(k) Submission

K251161 is an FDA 510(k) clearance for the ANTHEM? Fracture System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on August 18, 2025, 125 days after receiving the submission on April 15, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K251161 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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