Cleared Special

K052100 - MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH

K052100 is an FDA 510(k) clearance for MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH, manufactured by Proxy Biomedical , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Special 510(k) pathway after a 8-day FDA review.

K052100 · Proxy Biomedical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
8d
Days
Class 2
Risk

K052100 is an FDA 510(k) clearance for the MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH. 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 August 11, 2005 after a review of 8 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

FDA 510(k) Submission Details - K052100

510(k) Number K052100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2005
Decision Date August 11, 2005
Days to Decision 8 days
Submission Type Special
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
107d faster than avg
Panel avg: 115d · This submission: 8d
Pathway characteristics
Modification to existing cleared device.

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 332
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K052100.
VICRYL * MESH BAG
K051701 · Ethicon, Inc. · Sep 2005
INCLOSE SURGICAL MESH SYSTEM
K050969 · Anulex Technologies, Inc. · Aug 2005
ORTHOMEND
K051766 · Tei Biosciences, Inc. · Aug 2005
SURGI-WRAP MAST BIORESORBABLE SHEET
K050332 · Mast Biosurgery USA, Inc. · May 2005
MOTIFMESH SOFT TISSUE PATCH
K050678 · Proxy Biomedical , Ltd. · May 2005
REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH
K043191 · Angiologica B. M. Srl · May 2005