Cleared Traditional

K170780 - ARIX Foot System (2.3/2.8)

K170780 is an FDA 510(k) clearance for ARIX Foot System (2.3/2.8), 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 152-day FDA review.

K170780 · Jeil Medical Corporation · Orthopedic device
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Aug 2017
Decision
152d
Days
Class 2
Risk

K170780 is an FDA 510(k) clearance for the ARIX Foot System (2.3/2.8). 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 14, 2017 after a review of 152 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

FDA 510(k) Submission Details - K170780

510(k) Number K170780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2017
Decision Date August 14, 2017
Days to Decision 152 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
30d slower than avg
Panel avg: 122d · This submission: 152d
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 K170780.
OrthoPediatrics Titanium PediPlates® System
K171173 · OrthoPediatrics Corp. · Aug 2017
EVOS Small Fragment Plating System
K172262 · Smith & Nephew, Inc. · Aug 2017
ARIX Ankle Fibula Hook Plate System
K170979 · Jeil Medical Corporation · Aug 2017
Arzzt 3.5 / 4.5 Small & Large Fragments System
K162507 · Truemed Group, LLC · Aug 2017
ARIX Ankle Distal Tibia System
K170313 · Jeil Medical Corporation · Jul 2017
ARIX Diaphysis System
K171285 · Jeil Medical Corporation · Jul 2017