# K221520: Miro3D Wound Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Reprise Biomedical, Inc.
- Decided: Aug 18, 2022 after 85 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: 2 generations back to K061711 (2006). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140510: Miromatrix Wound Matrix, Miromatrix Medical, Inc. (2014) Summary page 5.

## Most influential descendants
- K223257: Miro3D Wound Matrix (2022), 3 descendants of its own
- K240753: Miro3D Fibers Wound Matrix (2024), 0 descendants of its own
- K240277: MiroDry Wound Matrix (2024), 0 descendants of its own
- K231614: MiroTract Wound Matrix (2023), 0 descendants of its own

## Indications for use
The Miro3D Wound Matrix is intended for the management of wounds including: Partial and full thickness wounds Pressure ulcers Venous ulcers Chronic vascular ulcers Diabetic ulcers Tunneled, undermined wounds Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) Draining wounds Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence)

Source page: https://510kreport.com/device/K221520
Methodology: https://510kreport.com/methodology