510(k) · Cleared
Recalled · Class II · 2023Durepair 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 Nov 2, 2016 as substantially equivalent to K063117 (Medtronic Neurosurgery, 2006) and 2 other predicates after a 169-day review. Its family tree reaches back 6 generations to 1995. 2 later devices descend from it. It has been recalled once.
- Decided
- Nov 2, 2016
- Review
- 169 days
- Class
- Class II
- Product code
- GXQ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 6 generations to K950956 (1995). 10 ancestors in all, the oldest K910555 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK950956 Dura-Guard Dural Repair Patch, Dura-Guard Dura SubstituteBio-Vascular, Inc. · 1995
- 5 generations backK973706 Dura-Guard-Dural Repair PatchBio-Vascular, Inc. · 1997
- 4 generations backK982282 Dura-Guard - Dural Repair PatchBio-Vascular, Inc. · 1998 · Recalled
- 3 generations backK041000 Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2004
- 2 generations backK052211 Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2005
- 1 generation backK063117 Modification to Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2006
- This deviceK161370 Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2016
- Descendant · cites it directly · 0 of its ownK251191 Collagen Dura Regeneration Membrane - RepairCollagen Matrix, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK250420 Helios Dura Regeneration MatrixHelios Biomedical, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K950956 | Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute | Bio-Vascular, Inc. | 1995 | — |
| −5 | K973706 | Dura-Guard-Dural Repair Patch | Bio-Vascular, Inc. | 1997 | — |
| −4 | K982282 | Dura-Guard - Dural Repair Patch | Bio-Vascular, Inc. | 1998 | 1 |
| −3 | K041000 | Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2004 | — |
| −2 | K052211 | Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2005 | — |
| −1 | K063117 | Modification to Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2006 | — |
| 0 (this device) | K161370 | Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2016 | — |
| +1 | K251191 | Collagen Dura Regeneration Membrane - Repair | Collagen Matrix, Inc. | 2025 | — |
| +1 | 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 |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K063117 | Modification to Durepair Dura Regeneration MatrixSummary page 4…Dura Substitute (21 CFR §882. 882.5910, Product Code GXQ) Predicate Device: Durepair Dura Regeneration Matrix (K063117, K041000 and K052211) Device Description: Durepair® Dura Regeneration Matrix is a collagen… | 2006 |
| * | K041000 | Durepair Dura Regeneration MatrixSummary page 4…(21 CFR §882. 882.5910, Product Code GXQ) Predicate Device: Durepair Dura Regeneration Matrix (K063117, K041000 and K052211) Device Description: Durepair® Dura Regeneration Matrix is a collagen implant for the repair of defects in the dura… | 2004 |
| * | K052211 | Durepair Dura Regeneration MatrixSummary page 4…FR §882. 882.5910, Product Code GXQ) Predicate Device: Durepair Dura Regeneration Matrix (K063117, K041000 and K052211) Device Description: Durepair® Dura Regeneration Matrix is a collagen implant for the repair of defects in the dura mater. Durep… | 2005 |
What descends from it? (2)
2 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 |
|---|---|---|---|---|
| Jun 13, 2023 | Class II | Z-2207-2023 | Process change control | Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-process and finished goods endotoxin testing, which may present clinically with signs and symptoms of an acute inflammatory process, comparable… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K251191 (Collagen Matrix, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GXQ devicesGXQ Dura Substitute: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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/K161370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161370: 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/K161370
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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