Cleared Traditional

NeoMatriX Wound Matrix (K181330) - FDA 510(k) Clearance

K181330 · Nextgen Biologics, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Oct 2018
Decision
146d
Days
-
Risk

K181330 is an FDA 510(k) clearance for the NeoMatriX Wound Matrix. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Nextgen Biologics, Inc. (Gainesville, US). The FDA issued a Cleared decision on October 11, 2018 after a review of 146 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. 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 Nextgen Biologics, Inc. devices

Submission Details

510(k) Number K181330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2018
Decision Date October 11, 2018
Days to Decision 146 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
31d slower than avg
Panel avg: 115d · This submission: 146d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Consultant

Hogan Lovells US LLP
Janice Hogan

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 - KGN Wound Dressing With Animal-derived Material(s)

All 73
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K181330.
MariGen Wound Extra
K190528 · Kerecis Limited · Jul 2019
ProgenaMatrix
K182010 · Cell Constructs I, LLC · Jan 2019
Geistlich Derma-Gide
K182838 · Geistlich Pharma AG · Nov 2018
SURECELL Gelling Fiber Wound Dressing
K173005 · Jiangsu Newvalue Medical Producst Co.,Ltd · May 2018
Cytal Wound Particulate
K180776 · Acell, Inc. · May 2018
XCelliStem Wound Powder
K172593 · Stemsys · Mar 2018