Dura Substitute
FDA product code GXQ · Class II (moderate risk) · 21 CFR 882.5910 · Neurology
43510(k) clearances
0PMA approvals
22recalls
Implantimplanted device
Manufacturers
- Integra LifeSciences Corp. 6
- Collagen Matrix, Inc. 5
- Medtronic Neurosurgery 4
- W. L. Gore & Associates, Inc. 3
- Acera Surgical, Inc. 3
- Aesculap, Inc. 3
- Bio-Vascular, Inc. 3
- Cook Biotech, Inc. 2
- Codman & Shurtleff, Inc. 2
- Synthes, Inc. 2
- Johnson & Johnson Professionals, Inc. 1
- Shelhigh, Inc. 1
- Bridger Biomed, Inc. 1
- Lifecell Corp. 1
- Integra Life Sciences Corporation 1
- Rti Surgical, Inc. 1
- LeMaitre Vascular, Inc. 1
- Synthes (USA) Products LLC 1
- Nurami Medical , Ltd. 1
- Helios Biomedical, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251191 | Collagen Dura Regeneration Membrane - RepairGXQ · Traditional | Collagen Matrix, Inc. | 11/18/2025SE |
| K250420 | Helios Dura Regeneration MatrixGXQ · Traditional | Helios Biomedical, Inc. | 05/14/2025SE |
| K223445 | ArtiFasciaGXQ · Traditional | Nurami Medical , Ltd. | 08/10/2023SE |
| K212943 | SyntheCel Dura RepairGXQ · Traditional | Synthes (USA) Products, LLC | 01/28/2022SE |
| K183513 | XenoSure Dura Biologic PatchGXQ · Traditional | LeMaitre Vascular, Inc. | 06/13/2019SE |
| K172603 | Cerafix Dura SubstituteGXQ · Traditional | Acera Surgical, Inc. | 11/27/2017SE |
| K163456 | DuraGen Secure Dural Regeneration MatrixGXQ · Special | Integra LifeSciences Corporation | 01/06/2017SE |
| K161370 | Durepair Dura Regeneration MatrixGXQ · Traditional | Medtronic Neurosurgery | 11/02/2016SE |
| K161278 | Cerafix Dura SubstituteGXQ · Traditional | Acera Surgical, Inc. | 08/08/2016SE |
| K153613 | Cerafix Dura SubstituteGXQ · Traditional | Acera Surgical, Inc. | 03/16/2016SE |
| K150825 | Collagen Dural Regeneration MatrixGXQ · Traditional | Collagen Matrix, Inc. | 11/20/2015SE |
| K152481 | DURAFORM Dural Graft ImplantGXQ · Special | Codman & Shurtleff, Inc. | 10/30/2015SE |
| K141608 | Collagen Dura MembraneGXQ · Traditional | Collagen Matrix, Inc. | 01/16/2015SE |
| K132850 | Bovine Pericardium Suturable Dural Graft, Tutopatch DM Graft, Tutoplast Bovine…GXQ · Traditional | Rti Surgical, Inc. | 03/31/2014SE |
| K131792 | Synthecel Dura Repair, Synthecel Dura OnlayGXQ · Traditional | Synthes, Inc. | 12/16/2013SE |
| K131015 | Biodesign Onlay Dural Graft or Biodesign Duraplasty GraftGXQ · Traditional | Cook Biotech, Inc. | 10/08/2013SE |
| K122791 | Lyoplant OnlayGXQ · Traditional | Aesculap, Inc. | 06/04/2013SE |
| K120600 | Duragen Secure Dural Regneration MatrixGXQ · Traditional | Integra Life Sciences | 06/15/2012SE |
| K113071 | Synthecel Dura Replacement DevicesGXQ · Traditional | Synthes | 01/09/2012SE |
| K092388 | Duragen Plus Dural Regeneration Matrix- Spinal Matrix, Model DP2013SM, Integra Spinal…GXQ · Traditional | Integra LifeSciences Corporation | 01/21/2010SE |
| K072207 | Duragen XS Dural Regeneration MatrixGXQ · Special | Integra Lifesciences Corp. | 08/23/2007SE |
| K061208 | Lifecell Dural Substitute MatrixGXQ · Traditional | Lifecell Corp. | 01/03/2007SE |
| K063117 | Modification to Durepair Dura Regeneration MatrixGXQ · Special | Medtronic Neurosurgery | 11/03/2006SE |
| K061487 | Duramatrix Collagen Dura Substitute Membrane - Onlay and SuturableGXQ · Special | Collagen Matrix, Inc. | 06/26/2006SE |
| K052211 | Durepair Dura Regeneration MatrixGXQ · Special | Medtronic Neurosurgery | 09/14/2005SE |
| K043427 | Duragen II Dural Regeneration MatrixGXQ · Special | Integra Lifesciences Corp. | 01/12/2005SE |
| K040888 | Duramatrix Collagen Dura Substitute MembraneGXQ · Traditional | Collagen Matrix, Inc. | 12/01/2004SE |
| K041000 | Durepair Dura Regeneration MatrixGXQ · Traditional | Medtronic Neurosurgery | 07/27/2004SE |
| K041518 | Codman Duraform Dural Graft ImplantGXQ · Special | Codman & Shurtleff, Inc. | 06/22/2004SE |
| K032693 | Duragen Plus Dural Graft MatrixGXQ · Special | Integra Lifesciences Corp. | 09/30/2003SE |
| K031850 | Durasis Dural SubstituteGXQ · Traditional | Cook Biotech, Inc. | 09/08/2003SE |
| K021477 | Preclude MVP Dura SubstituteGXQ · Traditional | W. L. Gore & Associates, Inc. | 11/08/2002SE |
| K982101 | Shelhigh No-React Dura ShieldGXQ · Traditional | Shelhigh, Inc. | 05/02/2000SE |
| K991413 | Codman Ethisorb Dura PatchGXQ · Traditional | Johnson & Johnson Professionals, Inc. | 03/13/2000SE |
| K982180 | Duragen Dural Graft MatrixGXQ · Traditional | Integra Lifesciences Corp. | 07/06/1999SE |
| K984534 | Preclude Acuseal Dura SubstituteGXQ · Traditional | W. L. Gore & Associates, Inc. | 03/15/1999SE |
| K982282 | Dura-Guard - Dural Repair PatchGXQ · Special | Bio-Vascular, Inc. | 07/30/1998SE |
| K980548 | Dura-Patch Model Dp-XxxGXQ · Traditional | Bridger Biomed, Inc. | 05/13/1998SE |
| K973706 | Dura-Guard-Dural Repair PatchGXQ · Traditional | Bio-Vascular, Inc. | 12/24/1997SE |
| K970851 | Lyoplant Dura Substitute(Various)GXQ · Traditional | Aesculap, Inc. | 12/09/1997SE |
| K960470 | Neuro-PatchGXQ · Traditional | Aesculap, Inc. | 05/10/1996SE |
| K953969 | Preclude Dura SubstituteGXQ · Traditional | W. L. Gore & Associates, Inc. | 11/01/1995SE |
| K950956 | Dura-Guard Dural Repair Patch, Dura-Guard Dura SubstituteGXQ · Traditional | Bio-Vascular, Inc. | 06/02/1995SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0834-2025 Class II | Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, SterileIncorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two… | Cook Biotech, Inc. | 11/22/2024Open, Classified |
| Z-0262-2025 Class II | Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694Out of specification endotoxin levels. | Integra LifeSciences Corp. | 09/26/2024Open, Classified |
| Z-2207-2023 Class II | Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA…Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-process and… | Medtronic Neurosurgery | 06/13/2023Open, Classified |
| Z-0669-2022 Class II | RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair…Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient… | Collagen Matrix, Inc. | 12/13/2021Terminated |
| Z-0668-2022 Class II | DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm)…Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient… | Collagen Matrix, Inc. | 12/13/2021Terminated |
| Z-1387-2016 Class II | SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura…It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post… | Synthes (USA) Products LLC | 12/08/2015Terminated |
| Z-1386-2016 Class II | SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura…It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post… | Synthes (USA) Products LLC | 12/08/2015Terminated |
| Z-1385-2016 Class II | SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura…It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post… | Synthes (USA) Products LLC | 12/08/2015Terminated |
| Z-1384-2016 Class II | SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura…It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post… | Synthes (USA) Products LLC | 12/08/2015Terminated |
| Z-1383-2016 Class II | SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura…It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post… | Synthes (USA) Products LLC | 12/08/2015Terminated |
| Z-0339-2014 Class II | Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura substitute for…Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and… | Synovis Surgical Innovations, Inc. | 10/28/2013Terminated |
| Z-1300-2013 Class II | Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | Integra LifeSciences Corporation | 03/28/2013Terminated |
| Z-1285-2013 Class II | DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | Integra LifeSciences Corporation | 03/28/2013Terminated |
| Z-1284-2013 Class II | DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | Integra LifeSciences Corporation | 03/28/2013Terminated |
| Z-1283-2013 Class II | Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | Integra LifeSciences Corporation | 03/28/2013Terminated |
| Z-1282-2013 Class II | Dural Graft Matrix DuraGen Dural Graft Matrix is an absorbable implant for repair of…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | Integra LifeSciences Corporation | 03/28/2013Terminated |
| Z-0454-2011 | DuraGen XS Dural Regeneration Matrix: 1 inch x 3 inches. Non Pyrogenic; Rx only;Integra…Test results no longer support a 3 year shelf life. | Integra LifeSciences Corp. | 09/29/2010Terminated |
| Z-0453-2011 | DuraGen XS Dural Regeneration Matrix: 5 inches x 7 inches. Non Pyrogenic; Rx…Test results no longer support a 3 year shelf life. | Integra LifeSciences Corp. | 09/29/2010Terminated |
| Z-0452-2011 | DuraGen XS Dural Regeneration Matrix: 4 inches x 5 inches. Non Pyrogenic; Rx…Test results no longer support a 3 year shelf life. | Integra LifeSciences Corp. | 09/29/2010Terminated |
| Z-0451-2011 | DuraGen XS Dural Regeneration Matrix: 3 inches x 3 inches. Non Pyrogenic; Rx…Test results no longer support a 3 year shelf life. | Integra LifeSciences Corp. | 09/29/2010Terminated |
| Z-0450-2011 | DuraGen XS Dural Regeneration Matrix: 2 inches x 2 inches. Non Pyrogenic; Rx…Test results no longer support a 3 year shelf life. | Integra LifeSciences Corp. | 09/29/2010Terminated |
| Z-1081-2010 | Suturable DuraGen Dural Regeneration Matrix; Non-Pyrogenic; Sterility guaranteed unless…One lot of Suturable DuraGen Dural Regeneration Matrix (# 1091575) did not pass stability testing at certain… | Integra LifeSciences Corp | 01/13/2010Terminated |