Cleared Traditional

K162461 - Endoform Plastics and Reconstructive Matrix (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K162461 · Aroa Biosurgery (Formerly Mesynthes Limited) · General & Plastic Surgery device
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Dec 2016
Decision
109d
Days
Class 2
Risk

K162461 is an FDA 510(k) clearance for the Endoform Plastics and Reconstructive Matrix. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Aroa Biosurgery (Formerly Mesynthes Limited) (Auckland, NZ). The FDA issued a Cleared decision on December 20, 2016 after a review of 109 days - within the typical 510(k) review window.

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 (Formerly Mesynthes Limited) devices

Submission Details

510(k) Number K162461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2016
Decision Date December 20, 2016
Days to Decision 109 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
5d faster than avg
Panel avg: 114d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 162
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