510(k) · Cleared
ClearedSyntheCel Dura Repair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (USA) Products, LLC · GXQ Dura Substitute
Cleared on Jan 28, 2022 as substantially equivalent to K113071 (Synthes, 2012) and 1 other predicate after a 135-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Jan 28, 2022
- Review
- 135 days
- Class
- Class II
- Product code
- GXQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K950956 (1995). 12 ancestors in all, the oldest K910555 (1992). No later device cites it as a predicate yet.
- 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 backK982180 Duragen Dural Graft MatrixIntegra Lifesciences Corp. · 1999 · Recalled
- 3 generations backK021477 Preclude MVP Dura SubstituteW. L. Gore & Associates, Inc. · 2002
- 2 generations backK113071 Synthecel Dura Replacement DevicesSynthes · 2012 · Recalled
- 1 generation backK131792 Synthecel Dura Repair, Synthecel Dura OnlaySynthes, Inc. · 2013 · Recalled
- This deviceK212943 SyntheCel Dura RepairSynthes (USA) Products, LLC · 2022
View 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 | K982180 | Duragen Dural Graft Matrix | Integra Lifesciences Corp. | 1999 | 1 |
| −3 | K021477 | Preclude MVP Dura Substitute | W. L. Gore & Associates, Inc. | 2002 | — |
| −2 | K113071 | Synthecel Dura Replacement Devices | Synthes | 2012 | 5 |
| −1 | K131792 | Synthecel Dura Repair, Synthecel Dura Onlay | Synthes, Inc. | 2013 | 5 |
| 0 (this device) | K212943 | SyntheCel Dura Repair | Synthes (USA) Products, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 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? (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 |
|---|---|---|---|
| * | K113071 | Synthecel Dura Replacement DevicesSummary page 4…SYNTHECEL® Dura Repair Regulation Number 21 CFR 882.5910 Device Class 2 Product Code(s) GXQ Predicate Devices SYNTHECEL® Dura Replacement Devices (K113071) SYNTHECEL® Dura Repair (K131792) Reference Device Durepair Dura Regeneration Matrix (K161370) Device… | 2012 |
| * | K131792 | Synthecel Dura Repair, Synthecel Dura OnlaySummary page 4….5910 Device Class 2 Product Code(s) GXQ Predicate Devices SYNTHECEL® Dura Replacement Devices (K113071) SYNTHECEL® Dura Repair (K131792) Reference Device Durepair Dura Regeneration Matrix (K161370) Device Description SYNTHECEL® Dura Repair is composed of bi… | 2013 |
| † | K161370 | Durepair Dura Regeneration Matrix | 2016 |
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 27 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- 4 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K113071.
How does its category compare?
All GXQ devicesGXQ Dura Substitute: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
SYNTHECEL Dura Repair is indicated as a dura replacement for the repair of dura mater in adults.
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/K212943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212943: SyntheCel Dura Repair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212943
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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