# K041000: Durepair Dura Regeneration Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Neurosurgery
- Decided: Jul 27, 2004 after 99 days
- Product code: GXQ (Dura Substitute)
- Device class: 2
- Regulation: 21 CFR 882.5910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K950956 (1995). 7 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982282: Dura-Guard - Dural Repair Patch, Bio-Vascular, Inc. (1998) Summary page 2.
- K982180: Duragen Dural Graft Matrix, Integra Lifesciences Corp. (1999) Summary page 2.

## Most influential descendants
- K052211: Durepair Dura Regeneration Matrix (2005), 5 descendants of its own
- K063117: Modification to Durepair Dura Regeneration Matrix (2006), 3 descendants of its own
- K161370: Durepair Dura Regeneration Matrix (2016), 2 descendants of its own
- K251191: Collagen Dura Regeneration Membrane - Repair (2025), 0 descendants of its own
- K250420: Helios Dura Regeneration Matrix (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K041000
Methodology: https://510kreport.com/methodology