# K143426: Wound Matrix TF

- Pathway: 510(k) (Special)
- Applicant: Miromatrix Medical, Inc.
- Decided: Jan 27, 2015 after 57 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.
No later device cites it as a predicate yet.
0 of 3 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 4.

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

Source page: https://510kreport.com/device/K143426
Methodology: https://510kreport.com/methodology