# K161370: Durepair Dura Regeneration Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Neurosurgery
- Decided: Nov 2, 2016 after 169 days
- Product code: GXQ (Dura Substitute)
- Device class: 2
- Regulation: 21 CFR 882.5910
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K950956 (1995). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063117: Modification to Durepair Dura Regeneration Matrix, Medtronic Neurosurgery (2006) Summary page 4.
- K041000: Durepair Dura Regeneration Matrix, Medtronic Neurosurgery (2004) Summary page 4.
- K052211: Durepair Dura Regeneration Matrix, Medtronic Neurosurgery (2005) Summary page 4.

## Most influential descendants
- K251191: Collagen Dura Regeneration Membrane - Repair (2025), 0 descendants of its own
- K250420: Helios Dura Regeneration Matrix (2025), 0 descendants of its own

## Recalls of this device
- Jun 13, 2023 · Class II · Z-2207-2023: Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-process and finished goods endotoxin testing, which may present clinically with signs and symptoms of an a

## Indications for use
Durepair is indicated as a dura substitute for the repair of the dura mater.

Source page: https://510kreport.com/device/K161370
Methodology: https://510kreport.com/methodology