Cleared Abbreviated

K061892 - PROPATCH SOFT TISSUE REPAIR MATRIX (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K061892 · Cryolife, Inc. · General & Plastic Surgery device
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.

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
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 132d · 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.