Cleared Traditional

K161864 - ARIX Foot System

K161864 is an FDA 510(k) clearance for ARIX Foot System, manufactured by Jeil Medical Corporation. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K161864 · Jeil Medical Corporation · Orthopedic device
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Aug 2016
Decision
26d
Days
Class 2
Risk

K161864 is an FDA 510(k) clearance for the ARIX Foot System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Jeil Medical Corporation (Seoul, KR). The FDA issued a Cleared decision on August 2, 2016 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Jeil Medical Corporation devices

FDA 510(k) Submission Details - K161864

510(k) Number K161864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2016
Decision Date August 02, 2016
Days to Decision 26 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
96d faster than avg
Panel avg: 122d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 1251
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K161864.
Tarsa-Link Stand-Alone Wedge Fixation System
K161037 · Life Spine, Inc. · Aug 2016
Distal Radius Plating System
K161292 · Miami Device Solutions, LLC · Aug 2016
Converge
K153573 · Biomedical Enterprises, Inc. · Aug 2016
Biomet Microfixation Sternal Closure System
K161896 · Biomet Microfixation · Aug 2016
Conventus Orthopaedics Ulna Fixation System
K161048 · Conventus Orthopaedics, Inc. · Jul 2016
CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System
K153374 · Orthocare · Jun 2016