Cleared Traditional

ARIX Femur Nail System

K252826 · Jeil Medical Corporation · Orthopedic
Dec 2025
Decision
96d
Days
Class 2
Risk

About This 510(k) Submission

K252826 is an FDA 510(k) clearance for the ARIX Femur Nail System, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Jeil Medical Corporation (Seoul, KR). The FDA issued a Cleared decision on December 10, 2025, 96 days after receiving the submission on September 5, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K252826 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 2025
Decision Date December 10, 2025
Days to Decision 96 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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