Prosthesis, Intervertebral Disc
FDA product code MJO · Class III (high risk) · Orthopedic
0510(k) clearances
15PMA approvals
15recalls
Implantimplanted device
PMA approvals
- P250042 BAGUERA®C Cervical Disc Prosthesis · Spineart USA, Inc. · 08/10/2026
- P250028 Synergy Disc · Synergy Spine Solutions, Inc. · 02/26/2026
- P200022 Simplify® Cervical Artificial Disc · Globus Medical, Inc. · 09/18/2020
- P170036 M6-C Artificial Cervical Disc · Spinal Kinetics, LLC · 02/06/2019
- P120024 Activl Artificial Disc · Highridge Medical, LLC · 06/11/2015
- P090029 Prestige LP Cervical Disc · Medtronic Sofamor Danek USA, Inc. · 07/24/2014
- P110009 Mobi-C Cervical Disc Prosthesis (Two-Level Indication) · Highridge Medical, LLC · 08/23/2013
- P110002 Mobi-C Cervical Disc Prosthesis (One-Level Indication) · Highridge Medical, LLC · 08/07/2013
- P100012 Nuvasive PCM Cervical Disc System · Nuvasive, Inc. · 10/26/2012
- P100003 Secure-C Artificial Cervical Disc · Globus Medical, Inc. · 09/28/2012
- P060023 Bryan Cervical Disc Prosthesis · Companion Spine France Sas · 05/12/2009
- P070001 Prodisc Tm-C Total Disc Replacement · Centinel Spine, LLC · 12/17/2007
- P060018 Prestige Cervical Disc System · Medtronic Sofamor Danek, Inc. · 07/16/2007
- P050010 Prodisc -L Total Disc Replacement Device · Centinel Spine, LLC · 08/14/2006
- P040006 Charite Artificial Disc · Depuy Spine, Inc. · 10/26/2004
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2051-2026 Class II | Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc…Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and… | Centinel Spine, Inc. | 03/20/2026Open, Classified |
| Z-2050-2026 Class II | Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and… | Centinel Spine, Inc. | 03/20/2026Open, Classified |
| Z-1426-2026 Class II | Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software…Products were mislabeled as the 6mm product but included the 5 mm product. | Centinel Spine, Inc. | 12/31/2025Open, Classified |
| Z-3213-2024 Class II | prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration… | Centinel Spine, Inc. | 07/18/2024Open, Classified |
| Z-3212-2024 Class II | prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration… | Centinel Spine, Inc. | 07/18/2024Open, Classified |
| Z-2459-2023 Class II | GRANVIA-C, REF numbers: a) A13111427, b) A13112567, c) A13113456, d) A13131516, e)…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… | Medicrea International | 07/12/2023Open, Classified |
| Z-1453-2022 Class II | Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6…Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item… | NuVasive Inc | 06/20/2022Open, Classified |
| Z-1406-2021 Class II | Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally…Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the… | Centinel Spine, Inc. | 03/05/2021Terminated |
| Z-1641-2018 Class II | Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL…The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc… | Medtronic Sofamor Danek USA Inc | 03/13/2018Terminated |
| Z-0143-2008 | Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #:…Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be… | Medtronic Sofamor Danek USA Inc | 09/04/2007Terminated |
| Z-0142-2008 | Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog:…Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be… | Medtronic Sofamor Danek USA Inc | 09/04/2007Terminated |
| Z-0141-2008 | Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #:…Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be… | Medtronic Sofamor Danek USA Inc | 09/04/2007Terminated |
| Z-0140-2008 | Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #:…Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be… | Medtronic Sofamor Danek USA Inc | 09/04/2007Terminated |
| Z-0139-2008 | Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #:…Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be… | Medtronic Sofamor Danek USA Inc | 09/04/2007Terminated |
| Z-0138-2008 | Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #:…Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be… | Medtronic Sofamor Danek USA Inc | 09/04/2007Terminated |