Cleared Traditional

A.L.P.S. Proximal Humerus Plating System

K251620 · Zimmer Biomet · Orthopedic
Jul 2025
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K251620 is an FDA 510(k) clearance for the A.L.P.S. Proximal Humerus Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Zimmer Biomet (Warsaw, US). The FDA issued a Cleared decision on July 25, 2025, 59 days after receiving the submission on May 27, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K251620 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 2025
Decision Date July 25, 2025
Days to Decision 59 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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