Cleared Special

K153633 - Endoform Reconstructive Template

K153633 is an FDA 510(k) clearance for Endoform Reconstructive Template, manufactured by Aroa Biosurgery Limited (Formerly Mesynthes Limited). The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Special 510(k) pathway after a 88-day FDA review.

K153633 · Aroa Biosurgery Limited (Formerly Mesynthes Limited) · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
88d
Days
Class 2
Risk

K153633 is an FDA 510(k) clearance for the Endoform Reconstructive Template. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Aroa Biosurgery Limited (Formerly Mesynthes Limited) (Auckland, NZ). The FDA issued a Cleared decision on March 15, 2016 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. 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 Aroa Biosurgery Limited (Formerly Mesynthes Limited) devices

FDA 510(k) Submission Details - K153633

510(k) Number K153633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2015
Decision Date March 15, 2016
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
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 77
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K153633.
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