Cleared Special

ARIX Hand System (K161746) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K161746 · Jeil Medical Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
89d
Days
Class 2
Risk

K161746 is an FDA 510(k) clearance for the ARIX Hand 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 September 21, 2016 after a review of 89 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Jeil Medical Corporation devices

Submission Details

510(k) Number K161746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2016
Decision Date September 21, 2016
Days to Decision 89 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Modification to existing cleared device.

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 696
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K161746.
EVOS Small Fragment Plating System
K162078 · Smith & Nephew, Inc. · Nov 2016
VLP Wrist Fracture System
K161665 · Smith & Nephew, Inc. · Nov 2016
Ulna Plating System
K162424 · Biomet, Inc. · Oct 2016
BIOFOAM Bone Wedge
K152062 · Wrightmedicaltechnologyinc · May 2016
Cable-Ready Cable Grip System: Cable-Ready Bone Plate System
K151716 · Zimmer, Inc. · Jan 2016
ORTHOLOC® 3Di Foot Plating Reconstruction System
K152974 · Wrightmedicaltechnologyinc · Dec 2015