Cleared Traditional

K212146 - Arthrex LoopLoc Knotless Suture

K212146 is the FDA 510(k) clearance for Arthrex LoopLoc Knotless Suture by Arthrex, Inc.. It is a Class 2 General & Plastic Surgery device (product code GAT) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K212146 · Arthrex, Inc. · General & Plastic Surgery device
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Oct 2021
Decision
108d
Days
Class 2
Risk

K212146 is an FDA 510(k) clearance for the Arthrex LoopLoc Knotless Suture. 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 October 25, 2021 after a review of 108 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Arthrex, Inc. devices

Submission Details

510(k) Number K212146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2021
Decision Date October 25, 2021
Days to Decision 108 days
Submission Type Traditional
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 faster than avg
Panel avg: 115d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 94
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K212146.
Arthrex SutureTape
K221354 · Arthrex, Inc. · Sep 2022
Zone Specific AIM
K220186 · Conmed Corporation · May 2022
PERMALOOP Suture, PERMATAPE Suture
K220219 · Medos International SARL · Apr 2022
EasyWhip
K210675 · Winter Innovations, Inc. · May 2021
DYNATAPE Suture
K203186 · Medos International SARL · Mar 2021
FAST-FIX FLEX
K203393 · Smith & Nephew, Inc. · Feb 2021