Cleared Traditional

Arthrex Humeral Plating System and Cerclage Button

K243995 · Arthrex, Inc. · Orthopedic
Mar 2025
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K243995 is an FDA 510(k) clearance for the Arthrex Humeral Plating System 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 26, 2025, 90 days after receiving the submission on December 26, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K243995 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2024
Decision Date March 26, 2025
Days to Decision 90 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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