Cleared Abbreviated

K060520 - VITAMESH MACROPOROUS PP SURGICAL MESH (FDA 510(k) Clearance)

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

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

Submission Details

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
85d faster than avg
Panel avg: 114d · This submission: 29d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 334
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K060520.
Parietene™ Flat Sheet Mesh
K253125 · Medtronic - Sofradim Production · Oct 2025
Onflex™ Mesh
K251955 · Davol Inc., Subsidiary of C. R. Bard, Inc. · Jul 2025
Bard® Mesh
K251557 · Davol, Inc. · Jun 2025
Parietene™ Macroporous Mesh (PPM5050 )
K250869 · Sofradim Production · Apr 2025
Bard Soft Mesh
K250098 · Davol, Inc. · Apr 2025
ProGrip™ Self-Gripping Polypropylene Mesh
K243315 · Sofradim Production · Jan 2025