FDA-approved cervical and lumbar arthroplasty devices
Device | Application | Design | Biomaterials | Endplate | Fixation | Kinematics | FDA IDE Approval | Manufacturer |
---|---|---|---|---|---|---|---|---|
Prestige ST | Cervical | Uniarticular ball and trough | Metal-on-metal articulation, stainless steel | Roughened surface | Vertebral body screws | Unconstrained | July 2007 | Medtronic |
Bryan | Cervical | Biarticular | Titanium alloy shells with polyurethane nucleus, saline lubricant | Applied porous coating | Milled, press-fit | Unconstrained | May 2009 | Medtronic |
ProDisc-C | Cervical | Uniarticular ball and socket | CCM endplate with UHMWE inlay, metal-on-polyurethane articulation | Roughened titanium | Central keel | Semi-constrained | December-2007 | Synthes Spine |
CHARITÉ | Lumbar | Biarticular ball and socket | CC endplates with UHMWPE sliding core | Titanium and calcium phosphate plasma spray | 6 Fixation teeth at cranial/caudal endplates | Unconstrained | October-2004 | Depuy Spine |
ProDisc-L | Lumbar | Uniarticular ball and socket | CCM endplates with UHMWPE insert | Titanium plasma spray | Large central keel, 2 lateral spikes | Semi-constrained | August 2006 | Synthes Spine |
Note:—CCM indicates cobalt-chrome-molybdenum, CC, cobalt-chrome alloy; IDE, Investigational Device Exemption.