# K243071: Bovine Dermis Collagen Dermal Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: Dec 19, 2024 after 83 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 K910944 (1991). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040211: Modification to: Collagen Topical Wound Dressing, Collagen Matrix, Inc. (2004) Summary page 5.
- K152600: Collagen Dental Wound Dressings, Collagen Matrix, Inc. (2016) Summary page 5.

## Indications for use
Bovine Dermis Collagen Dermal Matrix is indicated for the management of wounds, including: • Full thickness and Partial thickness wounds • Chronic wounds (e.g. pressure ulcers, venous ulcers, diabetic ulcers, chronic ulcers) • Surgical wounds (donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence) • Trauma wounds (abrasions, lacerations, and skin tears) • Draining wounds • Partial thickness burns

Source page: https://510kreport.com/device/K243071
Methodology: https://510kreport.com/methodology