# K132850: Bovine Pericardium Suturable Dural Graft, Tutopatch DM Graft, Tutoplast Bovine Pericardium DM

- Pathway: 510(k) (Traditional)
- Applicant: Rti Surgical, Inc.
- Decided: Mar 31, 2014 after 201 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). 9 ancestors in all.
No later device cites it as a predicate yet.
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.
- K982282: Dura-Guard - Dural Repair Patch, Bio-Vascular, Inc. (1998) Summary page 1.
- K970851: Lyoplant Dura Substitute (Various), Aesculap, Inc. (1997) Summary page 1.
- K061487: Duramatrix Collagen Dura Substitute Membrane - Onlay and Suturable, Collagen Matrix, Inc. (2006) Summary page 1.

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

Source page: https://510kreport.com/device/K132850
Methodology: https://510kreport.com/methodology