# K220317: PuraPly Micronized Wound Matrix (PuraPly MZ)

- Pathway: 510(k) (Traditional)
- Applicant: Organogenesis, Inc.
- Decided: Jul 1, 2022 after 148 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011026 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011026: Fortaderm Wound Dressing, Organogenesis, Inc. (2001) Summary page 5.

## Indications for use
PuraPly® Micronized Wound Matrix (PuraPly® MZ) is intended for the management of wounds that include: • Partial and full-thickness wounds • Pressure ulcers • Venous ulcers • Diabetic ulcers • Chronic vascular ulcers • Tunneled/undermined wounds • Surgical wounds (e.g., donor sites/grafts, post-Mohs’ surgery, post-laser surgery, Podiatric wound, and wound dehiscence). • Trauma wounds (e.g., abrasions, lacerations, and skin tears) • Partial thickness burns • Draining wounds The device is intended for single patient use only.

Source page: https://510kreport.com/device/K220317
Methodology: https://510kreport.com/methodology