510(k) · Cleared
ClearedCerafix Dura Substitute
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acera Surgical, Inc. · GXQ Dura Substitute
Cleared on Aug 8, 2016 as substantially equivalent to K153613 (Acera Surgical, Inc., 2016) after a 94-day review. Its family tree reaches back 3 generations to 1995. 6 later devices descend from it.
- Decided
- Aug 8, 2016
- Review
- 94 days
- Class
- Class II
- Product code
- GXQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K950956 (1995). 4 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK950956 Dura-Guard Dural Repair Patch, Dura-Guard Dura SubstituteBio-Vascular, Inc. · 1995
- 2 generations backK991413 Codman Ethisorb Dura PatchJohnson & Johnson Professionals, Inc. · 2000
- 1 generation backK153613 Cerafix Dura SubstituteAcera Surgical, Inc. · 2016
- This deviceK161278 Cerafix Dura SubstituteAcera Surgical, Inc. · 2016
- Descendant · cites it directly · 4 of its ownK170300 Restrata Wound MatrixAcera Surgical, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK193583 Restrata®Acera Surgical, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK254256 LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK260020 Redermo Wound MatrixBeijing Kreate Medical Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK223445 ArtiFasciaNurami Medical, Ltd. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K170300Restrata Wound MatrixAcera Surgical, Inc. · 2017 · cites it directly4descendants
- K193583Restrata®Acera Surgical, Inc. · 2020 · 2 generations on1descendant
- K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd. · 2026 · 2 generations on0descendants
- K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd. · 2026 · 2 generations on0descendants
- K223445ArtiFasciaNurami Medical, Ltd. · 2023 · cites it directly0descendants
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 | K991413 | Codman Ethisorb Dura Patch | Johnson & Johnson Professionals, Inc. | 2000 | — |
| −1 | K153613 | Cerafix Dura Substitute | Acera Surgical, Inc. | 2016 | — |
| 0 (this device) | K161278 | Cerafix Dura Substitute | Acera Surgical, Inc. | 2016 | — |
| +1 | K170300 | Restrata Wound Matrix | Acera Surgical, Inc. | 2017 | 1 |
| +2 | K193583 | Restrata® | Acera Surgical, Inc. | 2020 | 1 |
| +2 | K254256 | LUOFUCON® Wound Matrix | Huizhou Foryou Medical Devices Co., Ltd. | 2026 | — |
| +2 | K260020 | Redermo Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026 | — |
| +1 | K223445 | ArtiFascia | Nurami Medical, Ltd. | 2023 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K153613 | Cerafix Dura SubstituteSummary page 4…e Code –Classification GXQ 21 CFR 882.5910 : Class II Primary Predicate Device K153613 Cerafix® Dura Substitute Device Description Cerafix® Dura Substitu… | 2016 |
What descends from it? (6)
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)
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 21 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K170300 (Acera Surgical, Inc., 2017) has gone furthest, with 4 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?
The Cerafix Dura Substitute is indicated as a dura substitute for the repair of dura mater. This device is indicated for defects of 4.4 in2 (28.3 cm2) or less in area. For example, 4.0 in x 1.1 in (10.1 cm x 2.8 cm) would be an acceptable defect size.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161278 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161278: Cerafix Dura Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161278
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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