# K153690: PriMatrix Dermal Repair Scaffold

- Pathway: 510(k) (Traditional)
- Applicant: Tei Biosciences, Inc.
- Decided: Feb 22, 2016 after 61 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- Device class: U
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K881854 (1988). 13 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K131286: Primatrix Dermal Repair Scaffold, Tei Biosciences, Inc. (2013) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- May 23, 2023 · Class II · Z-2078-2023: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- May 23, 2023 · Class II · Z-2077-2023: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- May 23, 2023 · Class II · Z-2079-2023: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- Jun 15, 2017 · Class II · Z-0383-2018: During Final Assembly Operation, it was noticed that some of the PriMatrix Instructions for Use (IFUs) from Lot RM1608011 Part 520-002v10 contained extra pages and/or missing pages: " 22 IFUs containe

## 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-Moh’s 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/K153690
Methodology: https://510kreport.com/methodology