Cleared Traditional

K130547 - ENDOFORM RECONSTRUCTIVE TEMPLATE

K130547 is an FDA 510(k) clearance for ENDOFORM RECONSTRUCTIVE TEMPLATE, manufactured by Mesynthe, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K130547 · Mesynthe, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
88d
Days
Class 2
Risk

K130547 is an FDA 510(k) clearance for the ENDOFORM RECONSTRUCTIVE TEMPLATE. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Mesynthe, Ltd. (San Diego, US). The FDA issued a Cleared decision on May 31, 2013 after a review of 88 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.

FDA 510(k) Submission Details - K130547

510(k) Number K130547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2013
Decision Date May 31, 2013
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTM Device Classification - Class 2, Special Controls

Product Code FTM Mesh, Surgical
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 - FTM Mesh, Surgical

All 156
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K130547.
XENMATRIX SURGICAL GRAFT
K140501 · C. R. Bard · Apr 2014
MIROMATRIX BIOLOGICAL MESH
K134033 · Miromatrix Medical, Inc. · Mar 2014
MESO BILAYER SURGICAL MESH
K132025 · Kensey Nash Corporation Dba Dsm Biomedical · Oct 2013
FORTIVA PORCINE DERMIS
K123356 · Rti Biologics, Inc. · Mar 2013
COLLAGEN TENDON SHEET-D
K122048 · Rotation Medical, Inc. · Jan 2013
PERMACOL SURGICAL IMPLANT
K120605 · Covidien, LLC · May 2012
K130547 · ENDOFORM RECONSTRUCTIVE TEMPLATE
Download PDF FDA Summary Mesynthe, Ltd.