Cleared Traditional

K133770 - A.I.M. KNOTLESS MENISCAL REPAIR DEVICE

K133770 is an FDA 510(k) clearance for A.I.M. KNOTLESS MENISCAL REPAIR DEVICE, manufactured by Anchor Innovation Medical (A.I.M.). The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K133770 · Anchor Innovation Medical (A.I.M.) · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
181d
Days
Class 2
Risk

K133770 is an FDA 510(k) clearance for the A.I.M. KNOTLESS MENISCAL REPAIR DEVICE. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Anchor Innovation Medical (A.I.M.) (Rockville, US). The FDA issued a Cleared decision on June 10, 2014 after a review of 181 days - an extended review 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. 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 Anchor Innovation Medical (A.I.M.) devices

FDA 510(k) Submission Details - K133770

510(k) Number K133770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2013
Decision Date June 10, 2014
Days to Decision 181 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 115d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 115
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K133770.
Nexus Suture
K151009 · Baylis Medical Company, Inc. · Aug 2015
Stryker Suture Tape
K150584 · Stryker · Aug 2015
Force Fiber OrthoTape suture
K150438 · Teleflexmedical, Inc. · Apr 2015
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