# K210024: NeoMatriX Wound Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Nextgen Biologics, Inc.
- Decided: Oct 7, 2021 after 276 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: 10 generations back to K921895 (1992). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181330: NeoMatriX Wound Matrix, Nextgen Biologics, Inc. (2018) Summary page 4.

## 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, Moh’s surgery, post-laser surgery, podiatric, and wound dehiscience), • Trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears), • Draining wounds. The device is intended for one-time use.

Source page: https://510kreport.com/device/K210024
Methodology: https://510kreport.com/methodology