# K072113: Integra Flowable Wound Matrix, Model FWD301

- Pathway: 510(k) (Traditional)
- Applicant: Integra Lifesciences Corp.
- Decided: Oct 10, 2007 after 70 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: 4 generations back to K881854 (1988). 10 ancestors in all.
5 later devices descend from it; 5 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022127: Avagen Wound Dressing, Integra Lifesciences Corp. (2002) Summary page 1.
- K910944: Medifil, Biocore (1991) Summary page 1.

## Most influential descendants
- K250329: GeniPhys Collymer Self-Assembling Scaffold (2025), 0 descendants of its own
- K134037: Premvia (2014), 0 descendants of its own
- K110318: Excellagen (2011), 0 descendants of its own
- K102946: Coreleader Colla-Pad Model CS 03030 (2011), 0 descendants of its own
- K081724: Hydrolyzed Collagen with 10% Chondroitin Sulfate (Psgag, Polysulfated Glycosaminoglycan) Wound Gel (2008), 0 descendants of its own

## Recalls of this device
- Mar 31, 2019 · Class II · Z-1338-2019: Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months

## Indications for use
INTEGRATM Flowable Wound Matrix is indicated for the 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, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears) and draining wounds. The device is intended for one-time use.

Source page: https://510kreport.com/device/K072113
Methodology: https://510kreport.com/methodology