Cleared Traditional

K252826 - ARIX Femur Nail System

K252826 is an FDA 510(k) clearance for ARIX Femur Nail System, manufactured by Jeil Medical Corporation. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 96-day FDA review.

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

K252826 is an FDA 510(k) clearance for the ARIX Femur Nail System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Jeil Medical Corporation (Seoul, KR). The FDA issued a Cleared decision on December 10, 2025 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Jeil Medical Corporation devices

FDA 510(k) Submission Details - K252826

510(k) Number K252826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 122d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HSB Rod, Fixation, Intramedullary And Accessories

All 460
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K252826.
Active Intramedullary (AIM) Tibial Nail System
K252025 · Satori Orthopaedics, Inc. · Mar 2026
T2 Alpha Femur Retrograde Nailing System
K253640 · Stryker GmbH · Feb 2026
Affixus® Natural Nail® Proximal Humeral System
K253749 · Zimmer Switzerland Manufacturing GmbH · Dec 2025
Estremo Fibular Nail
K250197 · Citieffe S.R.L. · Oct 2025
DynaNail TTC Fusion System
K250628 · MedShape, Inc. · Sep 2025
T2 Alpha Humerus Nailing System
K251400 · Stryker GmbH · Aug 2025