What cervical total disc replacements are currently FDA approved for use in the United States

Current FDA-approved cervical total disc replacements include:

• Prestige® ST (Medtronic Sofamor Danek)

• Bryan® (Medtronic Sofamor Danek)

The Prestige ST was the first cervical TDR approved by the FDA for use in the United States. This device is composed of two stainless steel articulating components that attach to the adjacent cervical vertebrae with locking screws. The convex superior component moves in a relatively unconstrained manner in the groove located on the inferior component (Fig. 71-3).

The Bryan disc is a relatively unconstrained single-piece device consisting of porous, coated titanium endplates and a polyurethane core. The polyurethane nucleus between the endplates is surrounded by a polyurethane sheath that contains wear debris. Saline is injected into the sheath to provide lubrication and a dampening effect to resist axial loads (Fig. 71-4).

The ProDisc-C is similar to the lumbar version consisting of an articulating metal on ultra high-molecular-weight polyethylene ball and socket device. The endplates are cobalt-chromium-molybdenum alloy with a midline keel for fixation and a titanium plasma spray coating for bony ingrowth (Fig. 71-5).

Many alternative cervical disc replacement designs are currently under study both in the United States and internationally.

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Figure 71-3. A and B, The Prestige ST cervical disc (Medtronic Sofamor Danek). (From Singh K, Vaccaro AR, Albert TJ. Assessing the potential impact of total disc arthroplasty on surgeon practice patterns in North America. Spine J 2004;4:195S-201S.)

Figure 71-3. A and B, The Prestige ST cervical disc (Medtronic Sofamor Danek). (From Singh K, Vaccaro AR, Albert TJ. Assessing the potential impact of total disc arthroplasty on surgeon practice patterns in North America. Spine J 2004;4:195S-201S.)

Figure 71-4. A and B, The Bryan cervical disc (Medtronic Sofamor Danek). (From Singh K, Vaccaro AR, Albert TJ. Assessing the potential impact of total disc arthroplasty on surgeon practice patterns in North America. Spine J 2004;4:195S-201S.)

Figure 71-5. A and B, The ProDisc-C artificial disc (Synthes Spine). (From Slipman CW, Derby R, Simeone FA, et al. Interventional Spine: An Algorithmic Approach. Edinburgh: Saunders; 2007.)

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