Cleared Traditional

K050678 - MOTIFMESH SOFT TISSUE PATCH

K050678 is an FDA 510(k) clearance for 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 Traditional 510(k) pathway after a 65-day FDA review.

K050678 · 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
May 2005
Decision
65d
Days
Class 2
Risk

K050678 is an FDA 510(k) clearance for the 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 May 20, 2005 after a review of 65 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Proxy Biomedical , Ltd. devices

FDA 510(k) Submission Details - K050678

510(k) Number K050678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2005
Decision Date May 20, 2005
Days to Decision 65 days
Submission Type Traditional
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
50d faster than avg
Panel avg: 115d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K050678.
ORTHOMEND
K051766 · Tei Biosciences, Inc. · Aug 2005
MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH
K052100 · Proxy Biomedical , Ltd. · Aug 2005
SURGI-WRAP MAST BIORESORBABLE SHEET
K050332 · Mast Biosurgery USA, Inc. · 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
TISSUE FIXATION SYSTEM
K050418 · Tfs Manufacturing Pty, Ltd. · May 2005
PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES
K050187 · Sofradim Production · Feb 2005