Cleared Traditional

K131286 - PRIMATRIX DERMAL REPAIR SCAFFOLD

K131286 · Tei Biosciences, Inc. · General & Plastic Surgery device
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Aug 2013
Decision
91d
Days
-
Risk

K131286 is an FDA 510(k) clearance for the PRIMATRIX DERMAL REPAIR SCAFFOLD. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Tei Biosciences, Inc. (Boston, US). The FDA issued a Cleared decision on August 5, 2013 after a review of 91 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 Tei Biosciences, Inc. devices

FDA 510(k) Submission Details - K131286

510(k) Number K131286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2013
Decision Date August 05, 2013
Days to Decision 91 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
24d faster than avg
Panel avg: 115d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

KGN Device Classification - Class 0,

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

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

All 96
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K131286.
Geistlich Wound Matrix
K171842 · Geistlich Pharma AG · Nov 2017
Collagen Dental Wound Dressings
K152600 · Collagen Matrix, Inc. · Jun 2016
Dental Collagen Wound Dressing (Nova Tape and NovaPlug)
K142712 · Novabone Products, LLC · Jan 2015
COLLAGEN DENTAL WOUND DRESSINGS
K122115 · Collagen Matrix, Inc. · Nov 2012
INTEGRA WOUND MATRIX (THIN)
K113104 · Integra LifeSciences Corporation · Feb 2012
ATLAS WOUND MATRIX
K090954 · Wrightmedicaltechnologyinc · Jul 2009