# K140456: Bio-Connekt Wound Matrix

- Pathway: 510(k) (Traditional)
- Applicant: MLM Biologics, Inc.
- Decided: Jul 22, 2014 after 148 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: 7 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)
- K040283: Biopad, Euroresearch Srl (2005) Summary page 1.
- K112580: Collagen Wound Dressing, Dalim Tissen Co., Ltd. (2012) Summary page 1.
- K022127: Avagen Wound Dressing, Integra Lifesciences Corp. (2002) Summary page 1.

## Indications for use
The MLM Biologics bio-ConneKt Wound Matrix is a collagen-based wound dressing for the local management of moderately to heavy exuding wounds, including: * Partial and full thickness wounds * Draining wounds * Tunneling wounds * Pressure sores/ulcers * Venous ulcers * Chronic vascular ulcers * Diabetic ulcer * Trauma wounds (e.g.. abrasions, lacerations, partial thickness bums, skin tears) * Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs' surgery, podiatric wounds, dehisced surgical incisions)

Source page: https://510kreport.com/device/K140456
Methodology: https://510kreport.com/methodology