510(k) · Cleared
Recalled · Class II · 2013Duragen Dural Graft 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 Jul 6, 1999 as substantially equivalent to K970851 (Aesculap, Inc., 1997) and 3 other predicates after a 379-day review. Its family tree reaches back 2 generations to 1995. 30 later devices descend from it. It has been recalled once.
- Decided
- Jul 6, 1999
- Review
- 379 days
- Class
- Class II
- Product code
- GXQ
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K950956 (1995). 5 ancestors in all, the oldest K910555 (1992). 30 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK950956 Dura-Guard Dural Repair Patch, Dura-Guard Dura SubstituteBio-Vascular, Inc. · 1995
- 1 generation backK973706 Dura-Guard-Dural Repair PatchBio-Vascular, Inc. · 1997
- This deviceK982180 Duragen Dural Graft MatrixIntegra Lifesciences Corp. · 1999
- Descendant · cites it directly · 9 of its ownK032693 Duragen Plus Dural Graft MatrixIntegra Lifesciences Corp. · 2003 · Recalled
- Descendant · cites it directly · 7 of its ownK041000 Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2004
- Descendant · 2 generations on · 5 of its ownK052211 Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2005
- Descendant · 2 generations on · 3 of its ownK063117 Modification to Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2006
- Descendant · 2 generations on · 3 of its ownK043427 Duragen II Dural Regeneration MatrixIntegra Lifesciences Corp. · 2005 · Recalled
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K032693Duragen Plus Dural Graft MatrixIntegra Lifesciences Corp. · 2003 · cites it directly9descendants
- K041000Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2004 · cites it directly7descendants
- K052211Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2005 · 2 generations on5descendants
- K063117Modification to Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2006 · 2 generations on3descendants
- K043427Duragen II Dural Regeneration MatrixIntegra Lifesciences Corp. · 2005 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950956 | Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute | Bio-Vascular, Inc. | 1995 | — |
| −1 | K973706 | Dura-Guard-Dural Repair Patch | Bio-Vascular, Inc. | 1997 | — |
| 0 (this device) | K982180 | Duragen Dural Graft Matrix | Integra Lifesciences Corp. | 1999 | — |
| +1 | K032693 | Duragen Plus Dural Graft Matrix | Integra Lifesciences Corp. | 2003 | 1 |
| +1 | K041000 | Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2004 | — |
| +2 | K052211 | Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2005 | — |
| +2 | K063117 | Modification to Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2006 | — |
| +2 | K043427 | Duragen II Dural Regeneration Matrix | Integra Lifesciences Corp. | 2005 | 2 |
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 |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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? (5)
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 |
|---|---|---|---|
| * | K970851 | Lyoplant Dura Substitute (Various)Summary page 1…aGen™ Dural Graft Matrix is substantially equivalent in function and intended use to the following devices: a. I yoplant(o Dura Substitute, (Bovine Pericardium), 510(k) K970851 Manufactured for AESCULAP, Inc. b. Dura-Guard® Dural Repair Patch, (Bovine Pericardium), 510(k) K973706 Manufactured by BioVasc… | 1997 |
| * | K973706 | Dura-Guard-Dural Repair PatchSummary page 1…: a. I yoplant(o Dura Substitute, (Bovine Pericardium), 510(k) K970851 Manufactured for AESCULAP, Inc. b. Dura-Guard® Dural Repair Patch, (Bovine Pericardium), 510(k) K973706 Manufactured by BioVascular, Inc. c. Preclude® Dura Substitute, (Expanded polytetrafluroethylene), 510(k) K953967. Manufactured… | 1997 |
| * | K953969 | Preclude Dura Substitute Our OCR of the scanned summary read K953967, FDA’s number for Endoscopic Catheter (Act Medical, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Preclude® Dura Substitute”. | 1995 |
| * | K910555 | Tutoplast DuraSummary page 2…TEGRA LIFESCIENCES g} 013 Integra LifeSciences Corporation 510(k) K982180 - DuraGen™ Dural Graft Matrix d. TutoPlast® Processed Dura Mater, (Human Dura Mater), 510(k) K910555 Manufactured by Biodynamics International, Inc. e. Lyodura®, (Human Dura Mater) Manufactured for AESCULAP, Inc. Device Descript… | 1992 |
| * | — | Lyodura® Named without a submission number |
What descends from it? (30)
See all 307 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032693 | Duragen Plus Dural Graft Matrix | 2003 | 9 |
| K041000 | Durepair Dura Regeneration Matrix | 2004 | 7 |
| K040888 | Duramatrix Collagen Dura Substitute Membrane | 2004 | 3 |
| K021477 | Preclude MVP Dura Substitute | 2002 | 3 |
| K113071 | Synthecel Dura Replacement Devices | 2012 | 2 |
| K033395 | Codman Dural Graft Implant, Models 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476… | 2004 | 2 |
| K031850 | Durasis Dural Substitute | 2003 | 2 |
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-1282-2013 | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K032693 (Integra Lifesciences Corp., 2003) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K970851.
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™ Dural Graft Matrix is indicated as a dura substitute for the repair of dura mater.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982180 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982180: Duragen Dural Graft Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982180
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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