Cleared Traditional

Arthrex FibuLock Nail System

K252196 · Arthrex, Inc. · Orthopedic
Mar 2026
Decision
234d
Days
Class 2
Risk

About This 510(k) Submission

K252196 is an FDA 510(k) clearance for the Arthrex FibuLock Nail System, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on March 5, 2026, 234 days after receiving the submission on July 14, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K252196 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2025
Decision Date March 05, 2026
Days to Decision 234 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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