510(k) · Cleared
Recalled · Class II · 2015Synthecel Dura Replacement Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Jan 9, 2012 as substantially equivalent to K950956 (Bio-Vascular, Inc., 1995) and 4 other predicates after an 84-day review. Its family tree reaches back 4 generations to 1995. 2 later devices descend from it. It has been recalled 5 times.
- Decided
- Jan 9, 2012
- Review
- 84 days
- Class
- Class II
- Product code
- GXQ
- Recalls
- 5
- Predicates
- 5
Its longest line of descent runs back 4 generations to K950956 (1995). 10 ancestors in all, the oldest K910555 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK950956 Dura-Guard Dural Repair Patch, Dura-Guard Dura SubstituteBio-Vascular, Inc. · 1995
- 3 generations backK973706 Dura-Guard-Dural Repair PatchBio-Vascular, Inc. · 1997
- 2 generations backK982180 Duragen Dural Graft MatrixIntegra Lifesciences Corp. · 1999 · Recalled
- 1 generation backK021477 Preclude MVP Dura SubstituteW. L. Gore & Associates, Inc. · 2002
- This deviceK113071 Synthecel Dura Replacement DevicesSynthes · 2012
- Descendant · cites it directly · 1 of its ownK131792 Synthecel Dura Repair, Synthecel Dura OnlaySynthes, Inc. · 2013 · Recalled
- Descendant · cites it directly · 0 of its ownK212943 SyntheCel Dura RepairSynthes (USA) Products, LLC · 2022
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 |
|---|---|---|---|---|---|
| −4 | K950956 | Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute | Bio-Vascular, Inc. | 1995 | — |
| −3 | K973706 | Dura-Guard-Dural Repair Patch | Bio-Vascular, Inc. | 1997 | — |
| −2 | K982180 | Duragen Dural Graft Matrix | Integra Lifesciences Corp. | 1999 | 1 |
| −1 | K021477 | Preclude MVP Dura Substitute | W. L. Gore & Associates, Inc. | 2002 | — |
| 0 (this device) | K113071 | Synthecel Dura Replacement Devices | Synthes | 2012 | — |
| +1 | K131792 | Synthecel Dura Repair, Synthecel Dura Onlay | Synthes, Inc. | 2013 | 5 |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2022 | 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? (5)
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…Name Classification 21 CER 882.5910 Device Class 11 Review Panel Neurology Product Code(s) GXQ Predicate Devices Rio-Vascular's Dura-Guard (K950956, K973706,K982282) Integra Lifescience's DuraGen (K982180) Gore - Preclude MVP (K021477)… | 1995 |
| * | K973706 | Dura-Guard-Dural Repair PatchSummary page 1…ssification 21 CER 882.5910 Device Class 11 Review Panel Neurology Product Code(s) GXQ Predicate Devices Rio-Vascular's Dura-Guard (K950956, K973706,K982282) Integra Lifescience's DuraGen (K982180) Gore - Preclude MVP (K021477) Device… | 1997 |
| * | K982282 | Dura-Guard - Dural Repair PatchSummary page 1…ion 21 CER 882.5910 Device Class 11 Review Panel Neurology Product Code(s) GXQ Predicate Devices Rio-Vascular's Dura-Guard (K950956, K973706,K982282) Integra Lifescience's DuraGen (K982180) Gore - Preclude MVP (K021477) Device… | 1998 |
| * | K982180 | Duragen Dural Graft MatrixSummary page 1…el Neurology Product Code(s) GXQ Predicate Devices Rio-Vascular's Dura-Guard (K950956, K973706,K982282) Integra Lifescience's DuraGen (K982180) Gore - Preclude MVP (K021477) Device SyntheCel® Dura Replacement Devices (Onlay and Substitute… | 1999 |
| * | K021477 | Preclude MVP Dura SubstituteSummary page 1…icate Devices Rio-Vascular's Dura-Guard (K950956, K973706,K982282) Integra Lifescience's DuraGen (K982180) Gore - Preclude MVP (K021477) Device SyntheCel® Dura Replacement Devices (Onlay and Substitute) are Description composed of biosynthesiz… | 2002 |
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 |
|---|---|---|---|---|
| Dec 8, 2015 | Class II | Z-1385-2016 | Labeling False and Misleading | It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon intends to temporarily apply and subsequently remove a… |
| Dec 8, 2015 | Class II | Z-1384-2016 | Labeling False and Misleading | It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon intends to temporarily apply and subsequently remove a… |
| Dec 8, 2015 | Class II | Z-1383-2016 | Labeling False and Misleading | It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon intends to temporarily apply and subsequently remove a… |
| Dec 8, 2015 | Class II | Z-1387-2016 | Labeling False and Misleading | It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon intends to temporarily apply and subsequently remove a… |
| Dec 8, 2015 | Class II | Z-1386-2016 | Labeling False and Misleading | It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon intends to temporarily apply and subsequently remove a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K131792 (Synthes, Inc., 2013) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K950956.
How does its category compare?
All GXQ devicesGXQ Dura Substitute: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Replacement Devices are intended for use as a dura replacement for the repair of dura mater. SyntheCel® Dura Onlay is indicated for use in adults for the repair of dural defects and it can be placed without sutures. SyntheCel® Dura Substitute is indicated for use in adults for the repair of dural defects and it can be sutured into place.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113071 · printed Nov 4, 2026
Cite this page
510(k) Report. “K113071: Synthecel Dura Replacement Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K113071
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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