Cleared Special

K221354 - Arthrex SutureTape

K221354 is an FDA 510(k) clearance for Arthrex 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 122-day FDA review.

K221354 · Arthrex, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2022
Decision
122d
Days
Class 2
Risk

K221354 is an FDA 510(k) clearance for the Arthrex 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 September 9, 2022 after a review of 122 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K221354

510(k) Number K221354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2022
Decision Date September 09, 2022
Days to Decision 122 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
7d slower than avg
Panel avg: 115d · This submission: 122d
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 175
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K221354.
ACTIVBRAID™
K223822 · Embody, Inc. · Jun 2023
Arthrex BioSuture
K220880 · Arthrex, Inc. · Oct 2022
Arthrex SoftStitch
K222078 · Arthrex, Inc. · Sep 2022
Zone Specific AIM
K220186 · Conmed Corporation · May 2022
PERMALOOP Suture, PERMATAPE Suture
K220219 · Medos International SARL · Apr 2022
Arthrex LoopLoc Knotless Suture
K212146 · Arthrex, Inc. · Oct 2021
K221354 · Arthrex SutureTape
Download PDF FDA Summary Arthrex, Inc.