# K072207: Duragen XS Dural Regeneration Matrix

- Pathway: 510(k) (Special)
- Applicant: Integra Lifesciences Corp.
- Decided: Aug 23, 2007 after 15 days
- Product code: GXQ (Dura Substitute)
- Device class: 2
- Regulation: 21 CFR 882.5910
- Recalls of this device: 6 (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.
2 later devices descend from it; 1 cites 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)
- K032693: Duragen Plus Dural Graft Matrix, Integra Lifesciences Corp. (2003) Summary page 1.

## Most influential descendants
- K120600: Duragen Secure Dural Regneration Matrix (2012), 1 descendant of its own
- K163456: DuraGen Secure Dural Regeneration Matrix (2017), 0 descendants of its own

## Recalls of this device
- Mar 28, 2013 · Class II · Z-1285-2013: Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Mar 28, 2013 · Class II · Z-1286-2013: Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Sep 29, 2010 · Not classified · Z-0450-2011: Test results no longer support a 3 year shelf life.
- Sep 29, 2010 · Not classified · Z-0451-2011: Test results no longer support a 3 year shelf life.
- Sep 29, 2010 · Not classified · Z-0452-2011: Test results no longer support a 3 year shelf life.
- Sep 29, 2010 · Not classified · Z-0453-2011: Test results no longer support a 3 year shelf life.

## Indications for use
DuraGen XSTM Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.

Source page: https://510kreport.com/device/K072207
Methodology: https://510kreport.com/methodology