Cleared Traditional

K091499 - MEDEOR MATRIX, MODELS 30010-XX (HYDRATED) (FDA 510(k) Clearance)

Also includes:
30020-XX (DRY)

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

K091499 · Kensey Nash Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
154d
Days
Class 2
Risk

K091499 is an FDA 510(k) clearance for the MEDEOR MATRIX, MODELS 30010-XX (HYDRATED). Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Kensey Nash Corp. (Exton, US). The FDA issued a Cleared decision on October 22, 2009 after a review of 154 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 Kensey Nash Corp. devices

Submission Details

510(k) Number K091499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2009
Decision Date October 22, 2009
Days to Decision 154 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
40d slower than avg
Panel avg: 114d · This submission: 154d
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
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K091499.
Endoform Reconstructive Template - PLGA
K250598 · Aroa Biosurgery , Ltd. · Jun 2025
OviTex PRS (Long-Term Resorbable)
K243595 · TELA Bio, Inc. · Dec 2024
CanGaroo RM Antibacterial Envelope
K233991 · Elutia, Inc. · Jun 2024
OviTex PRS
K241126 · TELA Bio, Inc. · May 2024
Peri-Guard and Supple Peri-Guard
K223052 · Synovis Life Technologies, Inc. · Apr 2023
OviTex PRS (Long Term Resorbable)
K214070 · Tela Bio · Mar 2023