Cleared Traditional

K060165 - AXYAFLEX POLYESTER SUTURE

K060165 is the FDA 510(k) clearance for AXYAFLEX POLYESTER SUTURE by Axya Medical, Inc.. It is a Class 2 General & Plastic Surgery device (product code GAT) cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K060165 · Axya Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
221d
Days
Class 2
Risk

K060165 is an FDA 510(k) clearance for the AXYAFLEX POLYESTER SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Axya Medical, Inc. (Beverly, US). The FDA issued a Cleared decision on September 1, 2006 after a review of 221 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 Axya Medical, Inc. devices

Submission Details

510(k) Number K060165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2006
Decision Date September 01, 2006
Days to Decision 221 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
106d slower than avg
Panel avg: 115d · This submission: 221d
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 95
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K060165.
ARTHREX FIBERWIRE
K071622 · Arthrex, Inc. · Jul 2007
FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE
K070673 · Teleflexmedical, Inc. · Apr 2007
FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE
K063778 · Teleflex Medical · Feb 2007
SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE
K052652 · Smith & Nephew, Inc. · Oct 2005
ARTHREX SUTURE GRAFTING KIT
K041553 · Arthrex, Inc. · Dec 2004
ARTHREX FIBERWIRE WITH SILK
K041589 · Arthrex, Inc. · Aug 2004