Cleared Abbreviated

K061892 - PROPATCH SOFT TISSUE REPAIR MATRIX

K061892 is the FDA 510(k) clearance for PROPATCH SOFT TISSUE REPAIR MATRIX by Cryolife, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTM) cleared through the Abbreviated 510(k) pathway after a 142-day FDA review.

K061892 · Cryolife, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Nov 2006
Decision
142d
Days
Class 2
Risk

K061892 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 November 22, 2006 after a review of 142 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Cryolife, Inc. devices

Submission Details

510(k) Number K061892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2006
Decision Date November 22, 2006
Days to Decision 142 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 115d · This submission: 142d
Pathway characteristics
Standards-based clearance path.

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 45
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K061892.
WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08
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K062558 · Biomet Manufacturing Corp · Jun 2007
BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 1175106
K063178 · C.R. Bard, Inc. · Nov 2006
BARD COLLAMEND IMPLANT, MODELS 1175101, 1175102, 1175103, 1175104, 1175105
K052322 · C.R. Bard, Inc. · Apr 2006
TENDON WRAP TENDON PROTECTOR
K053655 · Integra LifeSciences Corporation · Feb 2006