Cleared Abbreviated

K060520 - VITAMESH MACROPOROUS PP SURGICAL MESH

K060520 is an FDA 510(k) clearance for VITAMESH MACROPOROUS PP SURGICAL MESH, manufactured by Proxy Biomedical , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Abbreviated 510(k) pathway after a 29-day FDA review.

K060520 · Proxy Biomedical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
29d
Days
Class 2
Risk

K060520 is an FDA 510(k) clearance for the VITAMESH MACROPOROUS PP SURGICAL MESH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Proxy Biomedical , Ltd. (Stillwater, US). The FDA issued a Cleared decision on March 28, 2006 after a review of 29 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. 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 Proxy Biomedical , Ltd. devices

FDA 510(k) Submission Details - K060520

510(k) Number K060520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2006
Decision Date March 28, 2006
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Standards-based clearance path.

FTL Device Classification - Class 2, Special Controls

Product Code FTL Mesh, Surgical, Polymeric
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 - FTL Mesh, Surgical, Polymeric

All 203
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K060520.
BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH
K061314 · Davol Inc., Sub. C. R. Bard, Inc. · Jun 2006
PROCEED SURGICAL MESH
K060713 · Ethicon, Inc. · May 2006
ATRIUM MEDICAL CORPORATION C-QUR MESH
K050311 · Atrium Medical Corp. · Mar 2006
POPMESH
K053424 · Caldera Medical, Inc. · Feb 2006
CALDERA MESH
K060004 · Caldera Medical, Inc. · Feb 2006
OPTILENE MESH LP
K053158 · Aesculap, Inc. · Jan 2006