Cleared Traditional

FORTAFLEX SURGICAL SLING (K011027) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K011027 · Organogenesis, Inc. · General & Plastic Surgery device
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May 2001
Decision
55d
Days
Class 2
Risk

K011027 is an FDA 510(k) clearance for the FORTAFLEX SURGICAL SLING. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Organogenesis, Inc. (Canton, US). The FDA issued a Cleared decision on May 30, 2001 after a review of 55 days - a notably fast clearance cycle.

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: 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 Organogenesis, Inc. devices

Submission Details

510(k) Number K011027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2001
Decision Date May 30, 2001
Days to Decision 55 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
60d faster than avg
Panel avg: 115d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 37
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K011027.
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K031969 · DePuy Orthopaedics, Inc. · Jul 2003
BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH
K031332 · C.R. Bard, Inc. · May 2003
SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K030782 · W.L. Gore & Associates, Inc. · Apr 2003
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K001738 · DePuy Orthopaedics, Inc. · Dec 2000
DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K982330 · Depuy, Inc. · Sep 1998
PROLENE POLYPROPYLENE MESH PLUG W/ ONLAY PATCH
K915774 · Ethicon, Inc. · Mar 1992