# K210580: InnovaMatrix FS

- Pathway: 510(k) (Special)
- Applicant: Triad Life Sciences, Inc.
- Decided: Apr 21, 2021 after 54 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)
- K193552: InnovaMatrix, Triad Life Sciences, Inc. (2020) Summary page 4.

## Indications for use
InnovaMatrix™ FS is indicated 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 intended for one-time use.

Source page: https://510kreport.com/device/K210580
Methodology: https://510kreport.com/methodology