# K131286: Primatrix Dermal Repair Scaffold

- Pathway: 510(k) (Traditional)
- Applicant: Tei Biosciences, Inc.
- Decided: Aug 5, 2013 after 91 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: 6 generations back to K881854 (1988). 12 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083440: Primatrix Dermal Repair Scaffold, Tei Biosciences, Inc. (2008) Summary page 1.
- K023778: Dressskin, Tei Biosciences, Inc. (2003) Summary page 1.

## Most influential descendants
- K153690: PriMatrix Dermal Repair Scaffold (2016), 4 descendants of its own
- K201577: MatriDerm (2021), 2 descendants of its own
- K261224: MatriDerm (2026), 0 descendants of its own
- K250864: MatriDerm pluS+ Bi-Layer (2025), 0 descendants of its own
- K250397: Helios Dermal Scaffold (2025), 0 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/K131286
Methodology: https://510kreport.com/methodology