Cleared Traditional

K171285 - ARIX Diaphysis System

K171285 is an FDA 510(k) clearance for ARIX Diaphysis 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 84-day FDA review.

K171285 · Jeil Medical Corporation · Orthopedic device
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Jul 2017
Decision
84d
Days
Class 2
Risk

K171285 is an FDA 510(k) clearance for the ARIX Diaphysis 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 July 24, 2017 after a review of 84 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 - K171285

510(k) Number K171285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2017
Decision Date July 24, 2017
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
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 1245
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K171285.
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K160553 · Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · Jun 2017
Distal Elbow Plating System
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