510(k) · Cleared
ClearedCodman Ethisorb Dura Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Professionals, Inc. · GXQ Dura Substitute
Cleared on Mar 13, 2000 as substantially equivalent to K950956 (Bio-Vascular, Inc., 1995) and 1 other predicate after a 325-day review. Its family tree reaches back 1 generation to 1995. 14 later devices descend from it.
- Decided
- Mar 13, 2000
- Review
- 325 days
- Class
- Class II
- Product code
- GXQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K950956 (1995). 2 ancestors in all. 14 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK950956 Dura-Guard Dural Repair Patch, Dura-Guard Dura SubstituteBio-Vascular, Inc. · 1995
- This deviceK991413 Codman Ethisorb Dura PatchJohnson & Johnson Professionals, Inc. · 2000
- Descendant · cites it directly · 7 of its ownK153613 Cerafix Dura SubstituteAcera Surgical, Inc. · 2016
- Descendant · 2 generations on · 6 of its ownK161278 Cerafix Dura SubstituteAcera Surgical, Inc. · 2016
- Descendant · 3 generations on · 4 of its ownK170300 Restrata Wound MatrixAcera Surgical, Inc. · 2017 · Recalled
- Descendant · cites it directly · 2 of its ownK033395 Codman Dural Graft Implant, Models 80-1471, 80-1472, 80-1473…Codman & Shurtleff, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK031850 Durasis Dural SubstituteCook Biotech, Inc. · 2003
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K153613Cerafix Dura SubstituteAcera Surgical, Inc. · 2016 · cites it directly7descendants
- K161278Cerafix Dura SubstituteAcera Surgical, Inc. · 2016 · 2 generations on6descendants
- K170300Restrata Wound MatrixAcera Surgical, Inc. · 2017 · 3 generations on4descendants
- K033395Codman Dural Graft Implant, Models 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476…Codman & Shurtleff, Inc. · 2004 · cites it directly2descendants
- K031850Durasis Dural SubstituteCook Biotech, Inc. · 2003 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950956 | Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute | Bio-Vascular, Inc. | 1995 | — |
| 0 (this device) | K991413 | Codman Ethisorb Dura Patch | Johnson & Johnson Professionals, Inc. | 2000 | — |
| +1 | K153613 | Cerafix Dura Substitute | Acera Surgical, Inc. | 2016 | — |
| +2 | K161278 | Cerafix Dura Substitute | Acera Surgical, Inc. | 2016 | — |
| +3 | K170300 | Restrata Wound Matrix | Acera Surgical, Inc. | 2017 | 1 |
| +1 | K033395 | Codman Dural Graft Implant, Models 80-1471, 80-1472, 80-1473, 80-1474… | Codman & Shurtleff, Inc. | 2004 | — |
| +1 | K031850 | Durasis Dural Substitute | Cook Biotech, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K950956 | Dura-Guard Dural Repair Patch, Dura-Guard Dura SubstituteSummary page 1…the dural defect until healing occurs. Examples of predicate products with these same characteristics include the Dura-Guard™ Dural Repair Patch by Bio-Vascular, Inc., (K950956) and the Neuro-Patch by Aesculap®, Inc. (K960470). The Dura Patch differs from the predicate devices only in that once it has ful… | 1995 |
| * | K960470 | Neuro-PatchSummary page 1…of predicate products with these same characteristics include the Dura-Guard™ Dural Repair Patch by Bio-Vascular, Inc., (K950956) and the Neuro-Patch by Aesculap®, Inc. (K960470). The Dura Patch differs from the predicate devices only in that once it has fulfilled its function and is no longer needed to co… | 1996 |
What descends from it? (14)
See all 143 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?
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?
The CODMAN ETHISORB™ Dura Patch is an absorbable, synthetic implant for
bridging defects of the 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/K991413 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991413: Codman Ethisorb Dura Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991413
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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