# K092926: Acell Matristem Wound Sheet

- Pathway: 510(k) (Special)
- Applicant: Acell, Inc.
- Decided: Oct 28, 2009 after 35 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: 6 generations back to K921895 (1992). 24 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021637: Acell Ubm Lyophilized Wound Dressing, Acell, Inc. (2002) Summary page 1.

## Most influential descendants
- K112409: Matristem Wound Matrix (2011), 7 descendants of its own
- K152721: Cytal Wound Matrix (2015), 6 descendants of its own
- K132343: Marigen Wound Dressing (2013), 5 descendants of its own
- K190528: MariGen Wound Extra (2019), 3 descendants of its own
- K241080: Kerecis Parvus (50207) (2024), 1 descendant of its own

## Indications for use
ACell® MatriStem® Wound Sheet 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-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree bums and skin tears) and draining wounds. The device is intended for one-time use.

Source page: https://510kreport.com/device/K092926
Methodology: https://510kreport.com/methodology