Cleared Traditional

K110581 - PROPATCH SOFT TISSUE REPAIR MATRIX

K110581 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 315-day FDA review.

K110581 · Cryolife, Inc. · General & Plastic Surgery device
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Jan 2012
Decision
315d
Days
Class 2
Risk

K110581 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 January 10, 2012 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

View all Cryolife, Inc. devices

FDA 510(k) Submission Details - K110581

510(k) Number K110581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2011
Decision Date January 10, 2012
Days to Decision 315 days
Submission Type Traditional
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
200d slower than avg
Panel avg: 115d · This submission: 315d
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 125
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K110581.
PERMACOL SURGICAL IMPLANT
K120605 · Covidien, LLC · May 2012
COLLAGEN RIBBON
K120019 · Wrightmedicaltechnologyinc · Feb 2012
SYNERGY TISSUE MATRIX
K113460 · Synovis Orthopedic & Woundcare · Jan 2012
COLLAGEN TENDON SHEET
K112423 · Rotation Medical, Inc. · Dec 2011
PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF
K112786 · Synovis Orthopedic and Woundcare, Inc. · Oct 2011
PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX
K111436 · Brennen Medical, LLC · Oct 2011