Cleared Traditional

K101587 - PROPATCH SOFT TISSUE REPAIR MATRIX

K101587 is an FDA 510(k) clearance for PROPATCH SOFT TISSUE REPAIR MATRIX, manufactured by Cryolife, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K101587 · Cryolife, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
101d
Days
Class 2
Risk

K101587 is an FDA 510(k) clearance for the PROPATCH SOFT TISSUE REPAIR MATRIX. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Cryolife, Inc. (Kennesaw, US). The FDA issued a Cleared decision on September 16, 2010 after a review of 101 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.

FDA 510(k) Submission Details - K101587

510(k) Number K101587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2010
Decision Date September 16, 2010
Days to Decision 101 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
14d faster than avg
Panel avg: 115d · This submission: 101d
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 163
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K101587.
XYLOS MACRO-POROUS SURGICAL MESH
K111584 · Xylos Corporation · Aug 2011
BIODESIGN NIPPLE RECONSTRUCTION CYLINDER
K110402 · Cook Biotech, Inc. · Jun 2011
MEDEOR MATRIX
K103787 · Kensey Nash Corp. · Feb 2011
KENSEY NASH ECM SURGICAL PATCH
K094061 · Kensey Nash Corporation · May 2010
MEDEOR MATRIX, MODELS 30010-XX (HYDRATED)
K091499 · Kensey Nash Corp. · Oct 2009
TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358
K091142 · Rti Biologics, Inc. · Aug 2009
K101587 · PROPATCH SOFT TISSUE REPAIR MATRIX
Download PDF FDA Summary Cryolife, Inc.