Table 4.
FDA PMA-approved spinal implants and prostheses
| Device trade name | PMA number | Device manufacturer | Year of original FDA clearance | Number of PMA supplements cleared | Year of withdrawal from market | Product lifespan (years) |
|---|---|---|---|---|---|---|
| Intervertebral body fusion devices | ||||||
| Ray Threaded Fusion Cage™ with Instrumentation | P950019 | Stryker Corp. | 1996 | 17 | NA | NA |
| Bak® Interbody Fusion System | P950002 | Zimmer, Inc. | 1996 | 14 | NA | NA |
| Inter Fix™ Threaded Fusion Device | P970015 | Medtronic Sofamor Danek USA, Inc. | 1999 | 23 | NA | NA |
| Brantigen I/F Cage® used with VSP® Spine Plates and Pedicle Screws | P960025 | DePuy Spine, Inc. | 1999 | 12 | NA | NA |
| Bak/Cervicle® Interbody Fusion System | P980048 | Sulzer Spine-Tech | 2001 | 4 | NA | NA |
| Affinty™ Cage System | P000028 | Medtronic Sofamor Danek USA, Inc. | 2002 | 8 | NA | NA |
| Intervertebral disc prostheses | ||||||
| Charité™ Artificial Disc | P040006 | DePuy Spine, Inc. | 2004 | 6 | 2012 | 8 |
| Prodisc®-L Total Disc Replacement Device | P050010 | Synthes Holding AG | 2006 | 15 | NA | NA |
| Prodisc® TM-C Total Disc Replacement | P070001 | Synthes Holding AG | 2007 | 12 | NA | NA |
| Prestige® Cervical Disc System | P060018 | Medtronic Sofamor Danek USA, Inc. | 2007 | 4 | NA | NA |
| Bryan® Cervical Disc Prosthesis | P060023 | Medtronic Sofamor Danek USA, Inc. | 2009 | 5 | NA | NA |
| Nuvasive® PCM Cervical Disc System | P100012 | Nuvasive, Inc. | 2012 | 6 | NA | NA |
| Secure®-C Artificial Cervical Disc System | P100003 | Globus Medical Inc. | 2012 | 4 | NA | NA |
| Mobi-C® Cervical Disc Prosthesis (Two-Level Indication) | P110009 | LDR Spine USA, Inc. | 2013 | 8 | NA | NA |
| Mobi-C® Cervical Disc Prosthesis (One-Level Indication) | P110002 | LDR Spine USA, Inc. | 2013 | 8 | NA | NA |
| Prestige® LP Cervical Disc | P090029 | Medtronic Sofamor Danek USA, Inc. | 2014 | 1 | NA | NA |
| Spinous process spacers | ||||||
| X-Stop® Interspinous Process Decompression System | P040001 | Medtronic Sofamor Danek USA, Inc. | 2005 | 19 | NA | NA |
| Coflex® Interlaminar Stabilization Device | P110008 | Paradigm Spine, LLC | 2012 | 3 | NA | NA |
NA = not applicable.