Cleared Traditional

K153632 - Endoform Reconstructive Template

K153632 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 FTL cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K153632 · Aroa Biosurgery Limited (Formerly Mesynthes Limited) · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
181d
Days
Class 2
Risk

K153632 is an FDA 510(k) clearance for the Endoform Reconstructive Template. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Aroa Biosurgery Limited (Formerly Mesynthes Limited) (Auckland, NZ). The FDA issued a Cleared decision on June 16, 2016 after a review of 181 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 Aroa Biosurgery Limited (Formerly Mesynthes Limited) devices

FDA 510(k) Submission Details - K153632

510(k) Number K153632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2015
Decision Date June 16, 2016
Days to Decision 181 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
66d slower than avg
Panel avg: 115d · This submission: 181d
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 204
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K153632.
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K153236 · C.R. Bard, Inc. · May 2016
GORE SYNECOR Biomaterial
K152609 · W.L. Gore & Associates, Inc. · Dec 2015
ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH
K143743 · C.R. Bard, Inc. · Sep 2015