Cleared Traditional

K131474 - ARTHREX DISTAL RADIUS PLATE SYSTEM

K131474 is an FDA 510(k) clearance for ARTHREX DISTAL RADIUS PLATE SYSTEM, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K131474 · Arthrex, Inc. · Orthopedic device
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Jul 2013
Decision
42d
Days
Class 2
Risk

K131474 is an FDA 510(k) clearance for the ARTHREX DISTAL RADIUS 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 Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on July 3, 2013 after a review of 42 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arthrex, Inc. devices

FDA 510(k) Submission Details - K131474

510(k) Number K131474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2013
Decision Date July 03, 2013
Days to Decision 42 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
80d faster than avg
Panel avg: 122d · This submission: 42d
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 1225
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K131474.
I.T.S. EXTREMITY FIXATION SYSTEMS
K131722 · I.T.S. GmbH · Aug 2013
NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0
K123347 · Normed Medizin-Technik GmbH · Aug 2013
STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW
K130731 · Stabiliz Orthopaedics, LLC · Jul 2013
EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM
K131480 · Emerge Medical · Jul 2013
LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT)
K131670 · Biomet, Inc. · Jul 2013
DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING
K130008 · I.T.S. GmbH · Jun 2013