Cleared Special

Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button

K260353 · Arthrex, Inc. · Orthopedic
Mar 2026
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K260353 is an FDA 510(k) clearance for the Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on March 3, 2026, 28 days after receiving the submission on February 3, 2026. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K260353 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2026
Decision Date March 03, 2026
Days to Decision 28 days
Submission Type Special
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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