Cleared Special

K111121 - VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH (FDA 510(k) Clearance)

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

K111121 · Proxy Biomedical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
22d
Days
Class 2
Risk

K111121 is an FDA 510(k) clearance for the VITAMESH (TM) BLUE LIGHTWEIGHT 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 May 13, 2011 after a review of 22 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Proxy Biomedical , Ltd. devices

Submission Details

510(k) Number K111121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2011
Decision Date May 13, 2011
Days to Decision 22 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 114d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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
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