Cleared Traditional

K073651 - NEOTRACT ANCHOR SYSTEM

K073651 is an FDA 510(k) clearance for NEOTRACT ANCHOR SYSTEM, manufactured by Neotract, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K073651 · Neotract, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
37d
Days
Class 2
Risk

K073651 is an FDA 510(k) clearance for the NEOTRACT ANCHOR SYSTEM. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Neotract, Inc. (Pleasanton, US). The FDA issued a Cleared decision on February 1, 2008 after a review of 37 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Neotract, Inc. devices

FDA 510(k) Submission Details - K073651

510(k) Number K073651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2007
Decision Date February 01, 2008
Days to Decision 37 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
78d faster than avg
Panel avg: 115d · This submission: 37d
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 110
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K073651.
FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT,
K092508 · Smith & Nephew, Inc. · Jan 2010
DUAL NEEDLE SUTURE PASSER SYSTEM
K082518 · Cayenne Medical, Inc. · Jan 2009
MENISCAL CINCH
K073149 · Arthrex, Inc. · Feb 2008
CAPSEW PLICATION SYSTEM
K071796 · Cayenne Medical, Inc. · Oct 2007
ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS
K072322 · Smith & Nephew, Inc. · Sep 2007
ARTHREX FIBERWIRE
K071622 · Arthrex, Inc. · Jul 2007