# K040888: Duramatrix Collagen Dura Substitute Membrane

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: Dec 1, 2004 after 240 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). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950956: Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute, Bio-Vascular, Inc. (1995) Summary page 1.
- K982180: Duragen Dural Graft Matrix, Integra Lifesciences Corp. (1999) Summary page 1.

## Most influential descendants
- K061487: Duramatrix Collagen Dura Substitute Membrane - Onlay and Suturable (2006), 1 descendant of its own
- K172603: Cerafix Dura Substitute (2017), 0 descendants of its own
- K132850: Bovine Pericardium Suturable Dural Graft, Tutopatch DM Graft, Tutoplast Bovine Pericardium DM (2014), 0 descendants of its own

## Indications for use
DuraMatrixTM Collagen Dura Substitute Membrane is indicated for use as a dural substitute for the repair of dura mater.

Source page: https://510kreport.com/device/K040888
Methodology: https://510kreport.com/methodology