# K181330: NeoMatriX Wound Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Nextgen Biologics, Inc.
- Decided: Oct 11, 2018 after 146 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 K921895 (1992). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152721: Cytal Wound Matrix, Acell, Inc. (2015) Summary page 4.
- K112409: Matristem Wound Matrix, Acell, Inc. (2011) Summary page 4.
- K061711: Oasis Wound Matrix, Cook Biotech, Inc. (2006) Summary page 4.

## Most influential descendants
- K210024: NeoMatriX Wound Matrix (2021), 0 descendants of its own

## Indications for use
NeoMatriX® Wound Matrix is intended for 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, and 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/K181330
Methodology: https://510kreport.com/methodology
