# K131015: Biodesign Onlay Dural Graft or Biodesign Duraplasty Graft

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech, Inc.
- Decided: Oct 8, 2013 after 180 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: 5 generations back to K950956 (1995). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031850: Durasis Dural Substitute, Cook Biotech, Inc. (2003)
- K043427: Duragen II Dural Regeneration Matrix, Integra Lifesciences Corp. (2005) Summary page 1.

## Indications for use
The Biodesign Onlay Dural Graft is intended for use as a dura substitute for repair of dura mater. The device is provided sterile and is intended for one-time use.

Source page: https://510kreport.com/device/K131015
Methodology: https://510kreport.com/methodology