Table 5.
Other FDA PMA-approved orthopaedic devices
| Device trade name | PMA number | Device manufacturer | Year of original FDA clearance | Number of PMA supplements cleared |
|---|---|---|---|---|
| Hyaluronic acid | ||||
| Synvisc-One® | P940015 | Genzyme Corp. | 1997 | 23 |
| Hyalgan® | P950027 | Fidia Farmaceutici SPA | 1997 | 11 |
| Supartz™ Dispo | P980044 | Seikagaku Corp. | 2001 | 2 |
| Euflexxa® (1% Sodium Hyaluronate) | P010029 | Ferring Pharmaceuticals, Inc. | 2004 | 6 |
| Orthovisc® High Molecular Weight Hyaluronan | P030019 | Anika Therapeutics, Inc. | 2004 | 12 |
| Gel-One® | P080020 | Seikagaku Corp. | 2011 | 13 |
| Sinovial® (0.8% Sodium Hyaluronate) | P110005 | Ibsa Institut Biochimique SA | 2014 | 1 |
| Monovisc® | P090031 | Anika Therapeutics, Inc. | 2014 | 3 |
| Bone cement | ||||
| Palacos® R Bone Cement | P810020 | Smith & Nephew Richard, Inc. | 1984 | 6 |
| DePuy 1 Bone Cement | P960001 | DePuy Orthopaedics Inc. | 1997 | 9 |
| Bone graft and filler | ||||
| Alveoform™ Biograft | P860012 | Collagen Corp. | 1988 | 5 |
| Pro Osteon® Implant 500 Hydroxyapatite Bone Void Filler | P860005 | Interpore Intl. | 1992 | 1 |
| Collagraft Bone Graft Substitute | P900039 | Neucoll, Inc. | 1993 | 1 |
| Infuse® Bone Graft/ LT-Cage® Lumar Tapered Fusion Device | P000058 | Medtronic Sofamor Danek USA, Inc. | 2002 | 49 |
| Infuse® Bone Graft | P000054 | Medtronic Sofamor Danek USA, Inc. | 2004 | 17 |
| Shock wave generator | ||||
| Orbasone™ Pain Relief System | P040039 | Orthometrix, Inc. | 2005 | 1 |
| Bone growth stimulator | ||||
| Orthopak® Bone Growth Stimulator | P850022 | Biolectron, Inc. | 1989 | 6 |
| OL1000/OL10000 SC and Spinalogic Bone Growth Stimulators | P910066 | DJ Orthopedics, LLC | 2012 | 1 |