Total disc replacement—FlexiCore
Fig. 21: FlexiCore artificial disc (larger view)
Fig. 22: FlexiCore artificial disc—
disc replacement between two vertebrae (larger view)
FlexiCore is a metal-on-metal device that is inserted as a single unit. The superior and inferior portions are linked by a captured ball-and-socket joint. The FlexiCore can be implanted from a straight anterior or an anterolateral direction, and offers the ability to manipulate the position of the implant within the intervertebral space. Unique domed baseplate surfaces are shaped to approximate the concavities of the vertebral body endplates, and are coated with titanium plasma spray to assist bone ongrowth fixation. See figure 21 and figure 22.
In the US FDA IDE study, FlexiCore was randomized to an anterior-posterior (360) fusion with anterior bone graft and posterolateral fusion using pedicle screws. Patients with single-level disc disease were studied. The randomized study has been completed, and Flexicore is now in Continued Access mode.
