# K100261: Primatrix AG Antimicrobial Dermal Dermal Repair Scaffold

- Pathway: 510(k) (Abbreviated)
- Applicant: Tei Biosciences, Inc.
- Decided: Dec 10, 2010 after 316 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K881854 (1988). 15 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 22 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.
- K043296: Colactive AG Collagen with Silver Antimicrobial Dressing, Covalontechnologies, Inc. (2005) Summary page 1.
- K083870: Exsalt SD7 Wound Dressing, Exciton Technologies, Inc. (2009) Summary page 1.

## Most influential descendants
- K120605: Permacol Surgical Implant (2012), 4 descendants of its own
- K160181: Colorado Therapeutics Xenograft Implant (2016), 1 descendant of its own
- K133011: Diaphragmatic Hernia Graft (2014), 1 descendant of its own
- K171817: Biodesign Diaphragmatic Hernia Graft (2018), 0 descendants of its own
- K172318: Endoform Silver Dermal Template (2017), 0 descendants of its own

## Recalls of this device
- May 23, 2023 · Class II · Z-2082-2023: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- May 23, 2023 · Class II · Z-2081-2023: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- May 23, 2023 · Class II · Z-2080-2023: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

## Indications for use
PriMatrix Ag Antimicrobial 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/K100261
Methodology: https://510kreport.com/methodology