Cleared Traditional

InnovaMatrix PD (K211902) - FDA 510(k) Clearance

K211902 · Triad Life Sciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2022
Decision
464d
Days
-
Risk

K211902 is an FDA 510(k) clearance for the InnovaMatrix PD. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Triad Life Sciences, Inc. (Memphis, US). The FDA issued a Cleared decision on September 28, 2022 after a review of 464 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Triad Life Sciences, Inc. devices

Submission Details

510(k) Number K211902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2021
Decision Date September 28, 2022
Days to Decision 464 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
349d slower than avg
Panel avg: 115d · This submission: 464d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

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 K211902.
FortiShield (Biosynthetic Wound Matrix)
K212579 · Organogenesis, Inc. · May 2023
Miro3D Wound Matrix
K223257 · Reprise Biomedical · Nov 2022
InnovaBurn
K213716 · Triad Life Sciences, Inc. · Sep 2022
LUOFUCON Collagen Wound Dressing
K213598 · Huizhou Foryou Medical Devices Co., Ltd. · Sep 2022
Miro3D Wound Matrix
K221520 · Reprise Biomedical, Inc. · Aug 2022
Foundation Dermal Regeneration Scaffold (DRS) Solo
K210949 · Bionova Medical, Inc. · Aug 2022