Cleared Traditional

PuraPly Micronized Wound Matrix (PuraPly MZ) (K220317) - FDA 510(k) Clearance

K220317 · Organogenesis, Inc. · General & Plastic Surgery device
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Jul 2022
Decision
148d
Days
-
Risk

K220317 is an FDA 510(k) clearance for the PuraPly Micronized Wound Matrix (PuraPly MZ). Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Organogenesis, Inc. (Canton, US). The FDA issued a Cleared decision on July 1, 2022 after a review of 148 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 Organogenesis, Inc. devices

Submission Details

510(k) Number K220317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2022
Decision Date July 01, 2022
Days to Decision 148 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
33d slower than avg
Panel avg: 115d · This submission: 148d
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 K220317.
Miro3D Wound Matrix
K221520 · Reprise Biomedical, Inc. · Aug 2022
Foundation Dermal Regeneration Scaffold (DRS) Solo
K210949 · Bionova Medical, Inc. · Aug 2022
PELNAC Meshed Bilayer Wound Matrix
K213498 · Gunze Limited · Jul 2022
Kerecis Silicone
K213231 · Kerecis Limited · Jun 2022
Fibrillar Collagen Wound Dressing
K213341 · Collagen Matrix, Inc. · May 2022
Geistlich Wound Matrix PLUS
K213607 · Geistlich Pharma AG · Apr 2022