Cleared Traditional

K180972 - ARIX Clavicle System

K180972 is the FDA 510(k) clearance for ARIX Clavicle System by Jeil Medical Corporation. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K180972 · Jeil Medical Corporation · Orthopedic device
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Oct 2018
Decision
173d
Days
Class 2
Risk

K180972 is an FDA 510(k) clearance for the ARIX Clavicle 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 October 3, 2018 after a review of 173 days - an extended review 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: 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

Submission Details

510(k) Number K180972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2018
Decision Date October 03, 2018
Days to Decision 173 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
51d slower than avg
Panel avg: 122d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 914
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K180972.
Geminus Volar Distal Radius Plate System
K182492 · Skeletal Dynamics, LLC · Oct 2018
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WishBone Medical Plate and Screw System
K180736 · Wishbone Medical, Inc. · Oct 2018
CoLink View Plating System
K182402 · In2bones USA, LLC · Sep 2018
Tandry Locking Plate System
K171904 · Microware Precision Co., Ltd. · Sep 2018
APTUS CMC-I Fusion Plate System
K181009 · Medartis AG · Aug 2018