Cleared Traditional

K131566 - ARIX HAND SYSTEM

K131566 is an FDA 510(k) clearance for ARIX HAND 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 158-day FDA review.

K131566 · Jeil Medical Corporation · Orthopedic device
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Nov 2013
Decision
158d
Days
Class 2
Risk

K131566 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 November 4, 2013 after a review of 158 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 - K131566

510(k) Number K131566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2013
Decision Date November 04, 2013
Days to Decision 158 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
36d slower than avg
Panel avg: 122d · This submission: 158d
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 1254
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K131566.
A.L.P.S. CALCANEAL PLATING SYSTEM
K132898 · Biomet Manufacturing Corp · Nov 2013
LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5
K131782 · Aap Implantate AG · Nov 2013
FLOWER ANKLE PLATING SET
K133102 · Flower Orthopedics Corporation · Nov 2013
WOLF LONG BONE PLATE SYSTEM
K131834 · Toby Orthopaedics · Nov 2013
2.5MM INLINE FUSION PLATE
K131867 · Biomet, Inc. · Oct 2013
VARIAX 2 SYSTEM
K132502 · Stryker Trauma AG · Oct 2013