510(k) · Cleared
ClearedArtiFascia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nurami Medical, Ltd. · GXQ Dura Substitute
Cleared on Aug 10, 2023 as substantially equivalent to K161278 (Acera Surgical, Inc., 2016) after a 269-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Aug 10, 2023
- Review
- 269 days
- Class
- Class II
- Product code
- GXQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K950956 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK950956 Dura-Guard Dural Repair Patch, Dura-Guard Dura SubstituteBio-Vascular, Inc. · 1995
- 3 generations backK991413 Codman Ethisorb Dura PatchJohnson & Johnson Professionals, Inc. · 2000
- 2 generations backK153613 Cerafix Dura SubstituteAcera Surgical, Inc. · 2016
- 1 generation backK161278 Cerafix Dura SubstituteAcera Surgical, Inc. · 2016
- This deviceK223445 ArtiFasciaNurami Medical, Ltd. · 2023
View 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 | K991413 | Codman Ethisorb Dura Patch | Johnson & Johnson Professionals, Inc. | 2000 | — |
| −2 | K153613 | Cerafix Dura Substitute | Acera Surgical, Inc. | 2016 | — |
| −1 | K161278 | Cerafix Dura Substitute | Acera Surgical, Inc. | 2016 | — |
| 0 (this device) | K223445 | ArtiFascia | Nurami Medical, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 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 |
|---|---|---|---|
| * | K161278 | Cerafix Dura SubstituteSummary page 4…ed: August 7, 2023 Name of Device: ArtiFascia Common or Usual Name: Dural Substitute Classification Name: Dura Substitute Predicate Devices: Cerafix Dura Substitute (K161278) Acera Surgical, Inc. Reference Devices: DuraGen Plus Dural Regeneration Matrix (K092388) Codman Ethisor… | 2016 |
| † | K092388 | Duragen Plus Dural Regeneration Matrix- Spinal Matrix, Model DP2013SM, Integra Spinal… | 2010 |
| † | K991413 | Codman Ethisorb Dura Patch | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 4 companies; a new generation was cleared every 7.0 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K161278.
How does its category compare?
All GXQ devicesGXQ Dura Substitute: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
ArtiFascia is indicated as dura substitute for the repair of dura mater. ArtiFascia is indicated for defects of 25cm2 (3.87 in2) or less in area. For example, 6 cm X 4 cm (24 cm2) would be an acceptable defect size.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223445 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223445: ArtiFascia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223445
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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