# K223257: Miro3D Wound Matrix

- Pathway: 510(k) (Special)
- Applicant: Reprise Biomedical
- Decided: Nov 21, 2022 after 31 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: 3 generations back to K061711 (2006). 3 ancestors in all.
3 later devices descend from it; 3 cite 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)
- K221520: Miro3D Wound Matrix, Reprise Biomedical, Inc. (2022) Summary page 4.

## Most influential descendants
- 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 indicated for the following: 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, partial thickness 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/K223257
Methodology: https://510kreport.com/methodology