FlexBACTM

 

FlexBACTM is a lumbar total disc replacement. The device employs a titanium alloy and exceptionally unique geometry to restore healthy spinal motion and stability. This includes proper limits of motion; healthy force-deflection behavior; and normal instantaneous centers of rotation and motion throughout flexion, extension, lateral bending and torsion. Further, this type of compliance, when properly employed, is known to eliminate measurable wear debris and to eliminate failure by fatigue.

Currently available spinal disc replacements are aimed at maintaining motion. However, not enough attention has been given to the quality of that motion. Therefore, the currently available surgical treatments for discogenic pain do not allow for restoring the spinal joints to their “safe zone”. That is to say that with existing medical devices the facet joints and adjacent segments are not kept within proper limits of motion and stress. This shortcoming can now be addressed as new research has increased understanding of spinal biomechanics and has generated a newly emerging field of engineering: compliant mechanisms. The novel application of compliant mechanisms to restoring proper biomechanics of the human spine inherently possesses the ability to restore healthy spinal motion (kinematics) and stability (kinetics). FlexBACTM is a properly engineered compliant mechanism for total disc replacement of a spinal segment and is intended to restore “safe zone” motion and stability without generating measurable wear debris or fatigue failure. FlexBACTM will provide for a significant improvement in the standard of medical care.

Products are not cleared for use.