510(k) · Cleared
ClearedDurepair Dura Regeneration Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Neurosurgery · GXQ Dura Substitute
Cleared on Jul 27, 2004 as substantially equivalent to K982282 (Bio-Vascular, Inc., 1998) and 1 other predicate after a 99-day review. Its family tree reaches back 3 generations to 1995. 7 later devices descend from it.
- Decided
- Jul 27, 2004
- Review
- 99 days
- Class
- Class II
- Product code
- GXQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K950956 (1995). 7 ancestors in all, the oldest K910555 (1992). 7 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK950956 Dura-Guard Dural Repair Patch, Dura-Guard Dura SubstituteBio-Vascular, Inc. · 1995
- 2 generations backK973706 Dura-Guard-Dural Repair PatchBio-Vascular, Inc. · 1997
- 1 generation backK982282 Dura-Guard - Dural Repair PatchBio-Vascular, Inc. · 1998 · Recalled
- This deviceK041000 Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2004
- Descendant · cites it directly · 5 of its ownK052211 Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2005
- Descendant · cites it directly · 3 of its ownK063117 Modification to Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2006
- Descendant · cites it directly · 2 of its ownK161370 Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK251191 Collagen Dura Regeneration Membrane - RepairCollagen Matrix, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK250420 Helios Dura Regeneration MatrixHelios Biomedical, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K052211Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2005 · cites it directly5descendants
- K063117Modification to Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2006 · cites it directly3descendants
- K161370Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2016 · cites it directly2descendants
- K251191Collagen Dura Regeneration Membrane - RepairCollagen Matrix, Inc. · 2025 · 2 generations on0descendants
- K250420Helios Dura Regeneration MatrixHelios Biomedical, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950956 | Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute | Bio-Vascular, Inc. | 1995 | — |
| −2 | K973706 | Dura-Guard-Dural Repair Patch | Bio-Vascular, Inc. | 1997 | — |
| −1 | K982282 | Dura-Guard - Dural Repair Patch | Bio-Vascular, Inc. | 1998 | 1 |
| 0 (this device) | K041000 | Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2004 | — |
| +1 | K052211 | Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2005 | — |
| +1 | K063117 | Modification to Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2006 | — |
| +1 | K161370 | Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2016 | 1 |
| +2 | K251191 | Collagen Dura Regeneration Membrane - Repair | Collagen Matrix, Inc. | 2025 | — |
| +2 | K250420 | Helios Dura Regeneration Matrix | Helios Biomedical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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? (2)
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 |
|---|---|---|---|
| * | K982282 | Dura-Guard - Dural Repair PatchSummary page 2…Predicate Manufacturer 510(k) Number Devices Dura-Guard ® Bio-Vascular K982282 DuraGen" Integra Life Sciences K982180 Summary of Technological Characteristics:… | 1998 |
| * | K982180 | Duragen Dural Graft MatrixSummary page 2…r Devices Dura-Guard ® Bio-Vascular K982282 DuraGen" Integra Life Sciences K982180 Summary of Technological Characteristics: Safety of the Durepair device to the predicate products was demo… | 1999 |
What descends from it? (7)
4 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 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, K052211 (Medtronic Neurosurgery, 2005) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K982282.
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?
Durepair® is indicated as a dura substitute for the repair of the dura mater.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041000 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041000: Durepair Dura 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/K041000
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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