# K231614: MiroTract Wound Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Reprise Biomedical, Inc.
- Decided: Dec 13, 2023 after 194 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: 4 generations back to K061711 (2006). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223257: Miro3D Wound Matrix, Reprise Biomedical (2022) Summary page 5.

## Indications for use
The MiroTract 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/K231614
Methodology: https://510kreport.com/methodology