# K061487: Duramatrix Collagen Dura Substitute Membrane - Onlay and Suturable

- Pathway: 510(k) (Special)
- Applicant: Collagen Matrix, Inc.
- Decided: Jun 26, 2006 after 26 days
- Product code: GXQ (Dura Substitute)
- Device class: 2
- Regulation: 21 CFR 882.5910
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K950956 (1995). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040888: Duramatrix Collagen Dura Substitute Membrane, Collagen Matrix, Inc. (2004) Summary page 1.

## Most influential descendants
- K132850: Bovine Pericardium Suturable Dural Graft, Tutopatch DM Graft, Tutoplast Bovine Pericardium DM (2014), 0 descendants of its own

## Recalls of this device
- Dec 13, 2021 · Class II · Z-0669-2022: Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
- Dec 13, 2021 · Class II · Z-0668-2022: Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery

## Indications for use
DuraMatrix T Collagen Dura Substitute Membranes are indicated as dural substitutes for the repair of dura mater.

Source page: https://510kreport.com/device/K061487
Methodology: https://510kreport.com/methodology