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The BioFlex® is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, failed previous fusion (pseudoarthrosis). In addition, the BioFlex® is indicated for use in patients: - . Who are receiving fusions with autogenous graft only; - . Who are having the device fixed or attached to the lumbar or sacral spine: - t Who are having the device removed after the development of a solid fusion mass.

The BioFlex® is comprised spring-like rods and pedicle screws. All components are manufactured from medical grade titanium alloy (Ti6Al4V).