# K021792: Bilayer Matrix Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Integra Lifesciences Corp.
- Decided: Aug 14, 2002 after 75 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: 3 generations back to K881854 (1988). 11 ancestors in all.
53 later devices descend from it; 9 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993948: Sis Wound Dressing II, Cook Biotech, Inc. (2000) Summary page 3.
- K014129: Promogran Matrix Wound Dressing, Johnson & Johnson Medical, Ltd. (2002) Summary page 3.
- K896455: Vitachoice Wound Dressing, Vitaphore Corp. (1990) Summary page 3.
- K896110: Biobrane (R) II, Sterling Drug, Inc. (1989) Summary page 3.

## Most influential descendants
- K092096: Endoform Dermal Template (2010), 19 descendants of its own
- K132397: Gore Bio-a Wound Matrix (2014), 10 descendants of its own
- K081635: Integra Meshed Bilayer Wound Matrix (2008), 10 descendants of its own
- K142879: BTM Wound Dressing (2015), 5 descendants of its own
- K132343: Marigen Wound Dressing (2013), 5 descendants of its own

## Recalls of this device
- Mar 10, 2009 · Not classified · Z-1174-2009: Package Seal Integrity: Integra became aware of the potential of open seals in the foil pouch of the Integra Bilayer Matrix Wound Dressings.

## Indications for use
Bilayer Matrix Wound Dressing is indicated for the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. The device is intended for one-time use.

Source page: https://510kreport.com/device/K021792
Methodology: https://510kreport.com/methodology