Cleared Special

K132043 - ARTHREX SPEEDCINCH

K132043 is an FDA 510(k) clearance for ARTHREX SPEEDCINCH, manufactured by Arthrex, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Special 510(k) pathway after a 29-day FDA review.

K132043 · Arthrex, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
29d
Days
Class 2
Risk

K132043 is an FDA 510(k) clearance for the ARTHREX SPEEDCINCH. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on July 31, 2013 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - the FDA general and plastic surgery device 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

FDA 510(k) Submission Details - K132043

510(k) Number K132043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2013
Decision Date July 31, 2013
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

GAT Device Classification - Class 2, Special Controls

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 145
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K132043.
ARTHREX BIOSUTURE
K140019 · Arthrex, Inc. · Jan 2014
TFCC FAST-FIX KIT
K132079 · Smith & Nephew, Inc. · Dec 2013
SMITH & NEPHEW ULTRATAPE
K132357 · Smith & Nephew, Inc. · Oct 2013
SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2
K122735 · Sorin Group USA, Inc. · May 2013
SMARTSTITCH PERFECTPASSER SYSTEM
K123268 · Arthocare Corporation · Nov 2012
SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N
K121861 · Smith & Nephew, Inc. · Oct 2012