# K061407: Primatrix Dermal Repair Scaffold

- Pathway: 510(k) (Special)
- Applicant: Tei Biosciences, Inc.
- Decided: Jun 29, 2006 after 38 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). 9 ancestors in all.
27 later devices descend from it; 2 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)
- K023778: Dressskin, Tei Biosciences, Inc. (2003) Summary page 1.

## Most influential descendants
- K083440: Primatrix Dermal Repair Scaffold (2008), 20 descendants of its own
- K100261: Primatrix AG Antimicrobial Dermal Dermal Repair Scaffold (2010), 6 descendants of its own
- K132343: Marigen Wound Dressing (2013), 5 descendants of its own
- K131286: Primatrix Dermal Repair Scaffold (2013), 5 descendants of its own
- K090812: Theraform Standard/Sheet (2009), 5 descendants of its own

## Indications for use
PriMatrix is intended for the management of wounds that include: • Partial and full thickness wounds * Pressure, diabetic, and venous 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

Source page: https://510kreport.com/device/K061407
Methodology: https://510kreport.com/methodology