Cleared Traditional

VitaMESH Macroporous PP Surgical Mesh (K172636) - FDA 510(k) Clearance

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

K172636 · Proxy Biomedical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
241d
Days
Class 2
Risk

K172636 is an FDA 510(k) clearance for the VitaMESH Macroporous PP Surgical Mesh. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Proxy Biomedical , Ltd. (Galway, IE). The FDA issued a Cleared decision on April 30, 2018 after a review of 241 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 Proxy Biomedical , Ltd. devices

Submission Details

510(k) Number K172636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2017
Decision Date April 30, 2018
Days to Decision 241 days
Submission Type Traditional
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
126d slower than avg
Panel avg: 115d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Paladin Medical, Inc.
Elaine Duncan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FTL Mesh, Surgical, Polymeric

All 132
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K172636.
ULTRAPRO Mesh and ULTRAPRO ADVANCED
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