# K043427: Duragen II Dural Regeneration Matrix

- Pathway: 510(k) (Special)
- Applicant: Integra Lifesciences Corp.
- Decided: Jan 12, 2005 after 30 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.
3 later devices descend from it; 3 cite it directly.
0 of 11 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
- K131015: Biodesign Onlay Dural Graft or Biodesign Duraplasty Graft (2013), 0 descendants of its own
- K122791: Lyoplant Onlay (2013), 0 descendants of its own
- K061208: Lifecell Dural Substitute Matrix (2007), 0 descendants of its own

## Recalls of this device
- Mar 28, 2013 · Class II · Z-1283-2013: 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.
- Jan 13, 2010 · Not classified · Z-1081-2010: One lot of Suturable DuraGen Dural Regeneration Matrix (# 1091575) did not pass stability testing at certain time points for Suture Retention Strength and Shrink Temperature specifications.

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

Source page: https://510kreport.com/device/K043427
Methodology: https://510kreport.com/methodology