Cleared Traditional

K160181 - COLORADO THERAPEUTICS XENOGRAFT IMPLANT

K160181 is an FDA 510(k) clearance for COLORADO THERAPEUTICS XENOGRAFT IMPLANT, manufactured by Colorado Therapeutics, LLC. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K160181 · Colorado Therapeutics, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
267d
Days
Class 2
Risk

K160181 is an FDA 510(k) clearance for the COLORADO THERAPEUTICS XENOGRAFT IMPLANT. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Colorado Therapeutics, LLC (Broomfield, US). The FDA issued a Cleared decision on October 20, 2016 after a review of 267 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Colorado Therapeutics, LLC devices

FDA 510(k) Submission Details - K160181

510(k) Number K160181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2016
Decision Date October 20, 2016
Days to Decision 267 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 115d · This submission: 267d
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 77
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K160181.
Biodesign Diaphragmatic Hernia Graft
K171817 · Cook Biotech Incorporated · Mar 2018
Gentrix Surgical Matrix Thick
K170763 · Acell, Inc. · Jun 2017
Gentrix Surgical Matrix
K162554 · Acell, Inc. · Oct 2016
Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix
K141084 · Acell, Inc. · Jun 2015
SIS HERNIA GRAFT
K133306 · Cook Biotech, Inc. · Jul 2014
PERMACOL SURGICAL IMPLANT
K120605 · Covidien, LLC · May 2012