Cleared Special

Affixus? Natural Nail? Proximal Humeral System

K253749 · Zimmer Switzerland Manufacturing GmbH · Orthopedic
Dec 2025
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K253749 is an FDA 510(k) clearance for the Affixus? Natural Nail? Proximal Humeral System, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Zimmer Switzerland Manufacturing GmbH (Winterthur, CH). The FDA issued a Cleared decision on December 12, 2025, 17 days after receiving the submission on November 25, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K253749 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 2025
Decision Date December 12, 2025
Days to Decision 17 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HSB — Rod, Fixation, Intramedullary And Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3020

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