Cleared Traditional

K092508 - FAST-FIX 360 MENISCAL REPAIR SYSTEM

K092508 is the FDA 510(k) clearance for FAST-FIX 360 MENISCAL REPAIR SYSTEM by Smith & Nephew, Inc.. It is a Class 2 General & Plastic Surgery device (product code GAT) cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K092508 · Smith & Nephew, Inc. · General & Plastic Surgery device
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Jan 2010
Decision
164d
Days
Class 2
Risk

K092508 is an FDA 510(k) clearance for the FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FI.... Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on January 28, 2010 after a review of 164 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K092508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2009
Decision Date January 28, 2010
Days to Decision 164 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
49d slower than avg
Panel avg: 115d · This submission: 164d
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 K092508.
ARTHREX BIO-SUTURE
K112899 · Arthrex, Inc. · Apr 2012
V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE
K103052 · Covidien, LLC · Nov 2010
FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK
K100506 · Teleflex Medical · Mar 2010
MENISCAL CINCH
K073149 · Arthrex, Inc. · Feb 2008
ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS
K072322 · Smith & Nephew, Inc. · Sep 2007
ARTHREX FIBERWIRE
K071622 · Arthrex, Inc. · Jul 2007