510(k) · Cleared
Recalled · Class II · 2013Duragen II Dural Regeneration Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Lifesciences Corp. · GXQ Dura Substitute
Cleared on Jan 12, 2005 as substantially equivalent to K032693 (Integra Lifesciences Corp., 2003) after a 30-day review. Its family tree reaches back 4 generations to 1995. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 12, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- GXQ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K950956 (1995). 7 ancestors in all, the oldest K910555 (1992). 3 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK950956 Dura-Guard Dural Repair Patch, Dura-Guard Dura SubstituteBio-Vascular, Inc. · 1995
- 3 generations backK973706 Dura-Guard-Dural Repair PatchBio-Vascular, Inc. · 1997
- 2 generations backK982180 Duragen Dural Graft MatrixIntegra Lifesciences Corp. · 1999 · Recalled
- 1 generation backK032693 Duragen Plus Dural Graft MatrixIntegra Lifesciences Corp. · 2003 · Recalled
- This deviceK043427 Duragen II Dural Regeneration MatrixIntegra Lifesciences Corp. · 2005
- Descendant · cites it directly · 0 of its ownK131015 Biodesign Onlay Dural Graft or Biodesign Duraplasty GraftCook Biotech, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK122791 Lyoplant OnlayAesculap, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK061208 Lifecell Dural Substitute MatrixLifecell Corp. · 2007
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K950956 | Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute | Bio-Vascular, Inc. | 1995 | — |
| −3 | K973706 | Dura-Guard-Dural Repair Patch | Bio-Vascular, Inc. | 1997 | — |
| −2 | K982180 | Duragen Dural Graft Matrix | Integra Lifesciences Corp. | 1999 | 1 |
| −1 | K032693 | Duragen Plus Dural Graft Matrix | Integra Lifesciences Corp. | 2003 | 1 |
| 0 (this device) | K043427 | Duragen II Dural Regeneration Matrix | Integra Lifesciences Corp. | 2005 | — |
| +1 | K131015 | Biodesign Onlay Dural Graft or Biodesign Duraplasty Graft | Cook Biotech, Inc. | 2013 | — |
| +1 | K122791 | Lyoplant Onlay | Aesculap, Inc. | 2013 | — |
| +1 | K061208 | Lifecell Dural Substitute Matrix | Lifecell Corp. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2013 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GXQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GXQ device
- #1 K251191 Collagen Dura Regeneration Membrane - Repairscore 12.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032693 | Duragen Plus Dural Graft MatrixSummary page 1…n HI Dural Regeneration Matrix is substantially equivalent in function and intended use to the currently marketed DuraGen PlusTM Dural Regeneration Matrix (K032693). Intended Use: DuraGen II DuralRegeneration Matrix is indicated as a dura substitute for the repair of dura mater.… | 2003 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 28, 2013 | Class II | Z-1283-2013 | Process control | 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 | Other | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K131015 (Cook Biotech, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K032693.
How does its category compare?
All GXQ devicesGXQ Dura Substitute: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GXQ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXQ
94in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXQ
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXQ
61in 2025
MAUDE reports naming product code GXQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 55 |
| 2008 | 0 | — | 0 | 43 |
| 2009 | 0 | — | 0 | 46 |
| 2010 | 1 | — | 6 | 36 |
| 2011 | 0 | — | 0 | 31 |
| 2012 | 2 | — | 0 | 38 |
| 2013 | 3 | 181 | 1 | 72 |
| 2014 | 1 | — | 0 | 18 |
| 2015 | 3 | 214 | 0 | 62 |
| 2016 | 3 | 94 | 0 | 58 |
| 2017 | 2 | — | 0 | 57 |
| 2018 | 0 | — | 0 | 94 |
| 2019 | 1 | — | 0 | 63 |
| 2020 | 0 | — | 0 | 114 |
| 2021 | 0 | — | 2 | 76 |
| 2022 | 1 | — | 0 | 59 |
| 2023 | 1 | — | 0 | 109 |
| 2024 | 0 | — | 2 | 55 |
| 2025 | 2 | — | 0 | 61 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
DuraGen II Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043427 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043427: Duragen II Dural Regeneration Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043427
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026