Cleared Special

MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH (K052100) - FDA 510(k) Clearance

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

K052100 · Proxy Biomedical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (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

Submission Details

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
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 115d · This submission: 8d
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 133
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K052100.
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
K053200 · W.L. Gore & Associates, Inc. · Dec 2005
BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED
K052155 · C.R. Bard, Inc. · Oct 2005
VICRYL * MESH BAG
K051701 · Ethicon, Inc. · Sep 2005
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K043056 · W.L. Gore & Associates, Inc. · Dec 2004
GORE POLYPROPYLENE HERNIA MESH
K043081 · W.L. Gore & Associates, Inc. · Dec 2004
BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004
K042026 · C.R. Bard, Inc. · Sep 2004