Cleared Traditional

Affixus Tibial Nailing System - 4mm screws

K243907 · Zimmer, Inc. · Orthopedic
Feb 2025
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K243907 is an FDA 510(k) clearance for the Affixus Tibial Nailing System - 4mm screws, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 12, 2025, 55 days after receiving the submission on December 19, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K243907 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 2024
Decision Date February 12, 2025
Days to Decision 55 days
Submission Type Traditional
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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