# K083440: Primatrix Dermal Repair Scaffold

- Pathway: 510(k) (Special)
- Applicant: Tei Biosciences, Inc.
- Decided: Dec 12, 2008 after 22 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). 11 ancestors in all.
20 later devices descend from it; 4 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061407: Primatrix Dermal Repair Scaffold, Tei Biosciences, Inc. (2006) Summary page 1.
- K061711: Oasis Wound Matrix, Cook Biotech, Inc. (2006) Summary page 1.

## Most influential descendants
- 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
- K153690: PriMatrix Dermal Repair Scaffold (2016), 4 descendants of its own
- K120605: Permacol Surgical Implant (2012), 4 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/K083440
Methodology: https://510kreport.com/methodology