Cleared Special

K091142 - TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358

K091142 is an FDA 510(k) clearance for TUTOPATCH, manufactured by Rti Biologics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Special 510(k) pathway after a 133-day FDA review.

K091142 · Rti Biologics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
133d
Days
Class 2
Risk

K091142 is an FDA 510(k) clearance for the TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, .... Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Rti Biologics, Inc. (Alachua, US). The FDA issued a Cleared decision on August 31, 2009 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K091142

510(k) Number K091142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2009
Decision Date August 31, 2009
Days to Decision 133 days
Submission Type Special
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
Modification to existing cleared device.

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 156
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K091142.
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K091499 · Kensey Nash Corp. · Oct 2009
XYLOS POROUS SURGICAL MESH
K090880 · Xylos Corporation · May 2009
MTA PROTECTIVE SHEET
K090778 · Xylos Corporation · Apr 2009
SECURIAN TISSUE REINFORCEMENT MATRIX
K083823 · Xylos Corporation · Mar 2009
K091142 · TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358
Download PDF FDA Summary Rti Biologics, Inc.