Cleared Traditional

A.L.P.S. Small Fragment Plating System

K243761 · Biomet Orthopedics · Orthopedic

Feb 2025

Decision

75d

Days

Class 2

Risk

About This 510(k) Submission

K243761 is an FDA 510(k) clearance for the A.L.P.S. Small Fragment Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Biomet Orthopedics (Warsaw, US). The FDA issued a Cleared decision on February 19, 2025, 75 days after receiving the submission on December 6, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K243761 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 06, 2024
Decision Date	February 19, 2025
Days to Decision	75 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF