# K182010: ProgenaMatrix

- Pathway: 510(k) (Traditional)
- Applicant: Cell Constructs I, LLC
- Decided: Jan 17, 2019 after 174 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K881854 (1988). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080949: Keratec Wound Dressings, Keratec Limited (2009) Summary page 4.

## Recalls of this device
- Apr 18, 2022 · Class II · Z-1137-2022: Inner pouch seal may be inadequate resulting in lack of sterility.

## Indications for use
ProgenaMatrix™ is indicated for dry and exuding partial and full thickness wounds such as: pressure (stage I-IV) and venous stasis ulcers, ulcers caused by mixed vascular etiologies, diabetic ulcers, donor sites and grafts, first and second degree burns, superficial injuries, cuts, abrasions and surgical wounds. ProgenaMatrix™ is not intended to be used on third degree burns.

Source page: https://510kreport.com/device/K182010
Methodology: https://510kreport.com/methodology