Cleared Special

K172937 - Colorado Therapeutics Xenograft Implant

K172937 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 Special 510(k) pathway after a 29-day FDA review.

K172937 · Colorado Therapeutics, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
29d
Days
Class 2
Risk

K172937 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 (Bloomfield, US). The FDA issued a Cleared decision on October 25, 2017 after a review of 29 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.

FDA 510(k) Submission Details - K172937

510(k) Number K172937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2017
Decision Date October 25, 2017
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 155
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K172937.
Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal
K182259 · Acell, Inc. · Feb 2019
CanGaroo Neuro Envelope (small)
K182255 · Aziyo Biologics, Inc. · Nov 2018
Biodesign Diaphragmatic Hernia Graft
K171817 · Cook Biotech Incorporated · Mar 2018
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large)
K173242 · Aziyo Biologics, Inc. · Oct 2017
Biodesign Parastomal Hernia Repair Graft
K162934 · Cook Biotech Incorporated · Jul 2017
Biodesign Fistula Plug
K170016 · Cook Biotech Incorporated · Jun 2017