# K112399: Unite Biomatrix

- Pathway: 510(k) (Special)
- Applicant: Synovis Orthopedic & Woundcare
- Decided: Sep 7, 2011 after 19 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: 5 generations back to K881854 (1988). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071425: Unite Biomatrix, Pegasus Biologics, Inc. (2007) Summary page 1.
- K061711: Oasis Wound Matrix, Cook Biotech, Inc. (2006) Summary page 1.

## Indications for use
The Synovis Orthopedic and Woundcare Unite® Biomatrix is an animal-derived extracellular matrix (xenograft) intended for the management of moderately to severely exudating 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 [second-degree] 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/K112399
Methodology: https://510kreport.com/methodology