Cleared Traditional

Affixus Retrograde Femoral Nailing System

K253566 · Zimmer, Inc. · Orthopedic
Mar 2026
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K253566 is an FDA 510(k) clearance for the Affixus Retrograde Femoral Nailing System, 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 March 12, 2026, 115 days after receiving the submission on November 17, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K253566 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 2025
Decision Date March 12, 2026
Days to Decision 115 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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