# K112409: Matristem Wound Matrix

- Pathway: 510(k) (Special)
- Applicant: Acell, Inc.
- Decided: Aug 29, 2011 after 7 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: 7 generations back to K921895 (1992). 25 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092926: Acell Matristem Wound Sheet, Acell, Inc. (2009) Summary page 1.

## Most influential descendants
- K152721: Cytal Wound Matrix (2015), 6 descendants of its own
- K192725: Cytal Wound Matrix 3-Layer (2019), 1 descendant of its own
- K181330: NeoMatriX Wound Matrix (2018), 1 descendant of its own
- K241724: Cytal® Wound Matrix; Cytal® Burn Matrix (2024), 0 descendants of its own
- K213607: Geistlich Wound Matrix PLUS (2022), 0 descendants of its own

## Indications for use
MatriStem® Wound Matrix is intended for the management of wounds including: partial and fuill-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunnellundermined wounds, surgical wounds (donor sites/grafts, post-Mohts 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/K112409
Methodology: https://510kreport.com/methodology