Cleared Traditional

K011025 - FORTAFLEX SURGICAL MESH

K011025 is an FDA 510(k) clearance for FORTAFLEX SURGICAL MESH, manufactured by Organogenesis, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K011025 · Organogenesis, Inc. · General & Plastic Surgery device
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Aug 2001
Decision
141d
Days
Class 2
Risk

K011025 is an FDA 510(k) clearance for the FORTAFLEX SURGICAL MESH. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Organogenesis, Inc. (Canton, US). The FDA issued a Cleared decision on August 24, 2001 after a review of 141 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 Organogenesis, Inc. devices

FDA 510(k) Submission Details - K011025

510(k) Number K011025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2001
Decision Date August 24, 2001
Days to Decision 141 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
26d slower than avg
Panel avg: 115d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTM Device Classification - Class 2, Special Controls

Product Code FTM Mesh, Surgical
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 - FTM Mesh, Surgical

All 152
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K011025.
TISSUEMEND SOFT TISSUE REPAIR MATRIX
K020455 · Tei Biosciences, Inc. · Apr 2002
FORTAFLEX SURGICAL MESH
K020049 · Organogenesis, Inc. · Mar 2002
PERMACOL
K013625 · Tissue Science Laboratories, Plc · Jan 2002
FORTAFLEX SURGICAL SLING
K011027 · Organogenesis, Inc. · May 2001
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K001738 · DePuy Orthopaedics, Inc. · Dec 2000
TUTOPATCH
K991296 · Tutogen Medical U.S., Inc. · Oct 2000