Cleared Traditional

K170979 - ARIX Ankle Fibula Hook Plate System

K170979 is the FDA 510(k) clearance for ARIX Ankle Fibula Hook Plate System by Jeil Medical Corporation. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K170979 · Jeil Medical Corporation · Orthopedic device
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Aug 2017
Decision
136d
Days
Class 2
Risk

K170979 is an FDA 510(k) clearance for the ARIX Ankle Fibula Hook Plate 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 17, 2017 after a review of 136 days - within the typical 510(k) review window.

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 K170979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2017
Decision Date August 17, 2017
Days to Decision 136 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
14d slower than avg
Panel avg: 122d · This submission: 136d
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 915
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K170979.
Arthrex Mesh Plate System
K170547 · Arthrex, Inc. · Sep 2017
OrthoPediatrics Titanium PediPlates® System
K171173 · OrthoPediatrics Corp. · Aug 2017
EVOS Small Fragment Plating System
K172262 · Smith & Nephew, Inc. · Aug 2017
ARIX Foot System (2.3/2.8)
K170780 · Jeil Medical Corporation · Aug 2017
ARIX Ankle Distal Tibia System
K170313 · Jeil Medical Corporation · Jul 2017
ARIX Diaphysis System
K171285 · Jeil Medical Corporation · Jul 2017