Cleared Special

K081538 - TUTOPATCH, TUTOMESH

K081538 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 17-day FDA review.

K081538 · 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
Jun 2008
Decision
17d
Days
Class 2
Risk

K081538 is an FDA 510(k) clearance for the TUTOPATCH, TUTOMESH. 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 June 19, 2008 after a review of 17 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. 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. Low regulatory complexity profile. 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 - K081538

510(k) Number K081538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2008
Decision Date June 19, 2008
Days to Decision 17 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
98d faster than avg
Panel avg: 115d · This submission: 17d
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 K081538.
COLLAMEND FM IMPLANT
K082687 · C.R. Bard, Inc. · Oct 2008
PORCINE SURGICAL MESH
K081272 · Brennen Medical, LLC · Jul 2008
MODIFICATION TO XYLOS SURGICAL MESH
K081882 · Xylos Corporation · Jul 2008
COLLAGEN TENDON WRAP
K080452 · Collagen Matrix, Inc. · May 2008
WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08
K073219 · American Medical Systems, Inc. · Apr 2008
SURGISIS BIODESIGN TISSUE GRAFT
K073391 · Cook Biotech, Inc. · Mar 2008
K081538 · TUTOPATCH, TUTOMESH
Download PDF FDA Summary Rti Biologics, Inc.