Cleared Special

K141735 - ARTHREX ANKLE FUSION PLATING SYSTEM

K141735 is the FDA 510(k) clearance for ARTHREX ANKLE FUSION PLATING SYSTEM by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Special 510(k) pathway after a 49-day FDA review.

K141735 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
49d
Days
Class 2
Risk

K141735 is an FDA 510(k) clearance for the ARTHREX ANKLE FUSION PLATING 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 August 15, 2014 after a review of 49 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 Arthrex, Inc. devices

Submission Details

510(k) Number K141735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2014
Decision Date August 15, 2014
Days to Decision 49 days
Submission Type Special
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
73d faster than avg
Panel avg: 122d · This submission: 49d
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 905
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K141735.
PRO-LINK WEDGE SYSTEM
K141905 · Life Spine · Sep 2014
DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM
K141796 · Synthes USA Products, LLC · Aug 2014
VALOR HINDFOOT FUSION NAIL SYSTEM
K142121 · Wrightmedicaltechnologyinc · Aug 2014
ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS
K140508 · Zimmer, Inc. · Aug 2014
ZIMMER PLATES AND SCREWS (ZPS)-NON-STERILE PLATES
K141517 · Zimmer, Inc. · Aug 2014
ZIMMER PERIARTICULAR LOCKING SYSTEM
K141734 · Zimmer, Inc. · Aug 2014