# K071425: Unite Biomatrix

- Pathway: 510(k) (Special)
- Applicant: Pegasus Biologics, Inc.
- Decided: Jun 20, 2007 after 28 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: 4 generations back to K881854 (1988). 11 ancestors in all.
25 later devices descend from it; 4 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061494: Dermadapt Wound Dressing, Pegasus Biologics, Inc. (2006) Summary page 1.

## Most influential descendants
- K092096: Endoform Dermal Template (2010), 19 descendants of its own
- K082103: LTM Wound Dressing (2008), 7 descendants of its own
- K132343: Marigen Wound Dressing (2013), 5 descendants of its own
- K200502: Myriad Particles (2021), 4 descendants of its own
- K231325: Corplex P / Theracor P / Allacor P (2024), 3 descendants of its own

## Indications for use
The Pegasus Biologics UniteTM Biomatrix is a collagen-based wound dressing for the local management of moderately to heavy exuding wounds, including: * Partial and full thickness wounds, * Draining wounds, * Pressure sores/ulcers, * Venous ulcers, * Chronic vascular ulcers, * Diabetic ulcers, * Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, 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/K071425
Methodology: https://510kreport.com/methodology