# K201577: MatriDerm

- Pathway: 510(k) (Traditional)
- Applicant: Medskin Solutions Dr. Suwelack AG
- Decided: Jan 7, 2021 after 210 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: 8 generations back to K881854 (1988). 14 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153690: PriMatrix Dermal Repair Scaffold, Tei Biosciences, Inc. (2016) Summary page 4.

## Most influential descendants
- K261224: MatriDerm (2026), 0 descendants of its own
- K250864: MatriDerm pluS+ Bi-Layer (2025), 0 descendants of its own

## Indications for use
MatriDerm is indicated for the management of wounds including: - Full thickness and partial thickness wounds - Chronic wounds (e.g. pressure ulcers, venous ulcers, diabetic ulcers, chronic ulcers) - Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence) - Partial thickness burns - Trauma wounds (abrasions, lacerations and skin tears) - Draining wounds

Source page: https://510kreport.com/device/K201577
Methodology: https://510kreport.com/methodology