# K113866: Porcine Dermal Xenografts Porcine Dermal Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Brennen Medical, LLC
- Decided: Mar 23, 2012 after 84 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: 11 generations back to K921895 (1992). 64 ancestors in all.
No later device cites it as a predicate yet.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111436: Porcine Surgical Mesh, Porcine Dermal Matrix, Brennen Medical, LLC (2011)
- K082103: LTM Wound Dressing, Lifecell Corp. (2008) Summary page 1.
- K083440: Primatrix Dermal Repair Scaffold, Tei Biosciences, Inc. (2008) Summary page 1.

## Indications for use
Porcine Dermal Xenograft is intended for the management of wounds that include: Partial and full thickness wounds; Pressure, diabetic, and venous ulcers; Chronic vascular ulcers; Second-degree burns; Surgical wounds-donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence; Trauma wounds-abrasions, lacerations, and skin tears; Tunneled/undermined wounds; Draining wounds. The Porcine Dermal Xenograft provides an environment that supports wound healing and control of minor bleeding. The device is intended for single patient, one time use only.

Source page: https://510kreport.com/device/K113866
Methodology: https://510kreport.com/methodology