Cleared Traditional

K093799 - TORNIER SURGICAL MESH

K093799 is an FDA 510(k) clearance for TORNIER SURGICAL MESH, manufactured by Tornier, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K093799 · Tornier, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
133d
Days
Class 2
Risk

K093799 is an FDA 510(k) clearance for the TORNIER SURGICAL MESH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Tornier, Inc. (Beverly, US). The FDA issued a Cleared decision on April 22, 2010 after a review of 133 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - 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 Tornier, Inc. devices

FDA 510(k) Submission Details - K093799

510(k) Number K093799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2009
Decision Date April 22, 2010
Days to Decision 133 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
18d slower than avg
Panel avg: 115d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTL Device Classification - Class 2, Special Controls

Product Code FTL Mesh, Surgical, Polymeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 - FTL Mesh, Surgical, Polymeric

All 249
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K093799.
ASCEND BLUE AC MESH
K101462 · Caldera Medical, Inc. · Aug 2010
VENTRALIGHT ST MESH
K101851 · Davol Inc., Sub. C. R. Bard, Inc. · Jul 2010
PARIE TENE PROGRIP MESH
K101197 · Sofradim Production · May 2010
VENTRIO HERNIA PATCH
K100229 · C.R. Bard, Inc. · Apr 2010
ATRIUM C-QUR OVT MESH
K100076 · Atrium Medical Corp. · Jan 2010
BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160
K092032 · Davol Inc., Sub. C. R. Bard, Inc. · Dec 2009