# K261224: MatriDerm

- Pathway: 510(k) (Special)
- Applicant: Medskin Solutions Dr. Suwelack AG
- Decided: May 14, 2026 after 30 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: 9 generations back to K881854 (1988). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201577: MatriDerm, Medskin Solutions Dr. Suwelack AG (2021) Summary page 5.

## Indications for use
MatriDerm is indicated for the management of wounds including: • Partial and full-thickness wounds • Chronic wounds (e.g. pressure ulcers, venous ulcers, diabetic 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 MatriDerm is sterile and for single use only.

Source page: https://510kreport.com/device/K261224
Methodology: https://510kreport.com/methodology