Cleared Special

K171296 - SutureTape

K171296 is an FDA 510(k) clearance for SutureTape, 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 24-day FDA review.

K171296 · Arthrex, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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May 2017
Decision
24d
Days
Class 2
Risk

K171296 is an FDA 510(k) clearance for the SutureTape. 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 May 26, 2017 after a review of 24 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 - K171296

510(k) Number K171296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2017
Decision Date May 26, 2017
Days to Decision 24 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
91d faster than avg
Panel avg: 115d · This submission: 24d
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 K171296.
Force Fiber Fusion Suture
K172016 · Teleflex Medical Incorporated · Oct 2017
GRAVITY™ Soft Tissue Repair System
K170642 · Wrightmedicaltechnologyinc · Aug 2017
Infinity-Lock 3, Infinity-Lock 5
K171680 · Xiros, Ltd. · Jun 2017
ExpressBraid Graft Manipulation
K163651 · Biomet Manufacturing Corp · Feb 2017
SpeedStitch Suture Passer
K163142 · ArthroCare Corporation · Jan 2017
MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture
K160854 · Biomet Manafacturing Corp. · Dec 2016