Flexuspine: IDE for FSU (Orthopedics This Week)
FDA has granted conditional approval to begin the initial phase of the Investigational Device Exemption (IDE) for a feasibility study of its Functional Spinal Unit (FSU). As indicated by the company, this is the first approved clinical study for a Total Spine Arthroplasty system in the U.S.
The FSU, which contains an interbody disc component (Core) and posterior dynamic resistance component (Dampener), is designed to provide an alternative to fusion by reestablishing mobility in an affected segment of the lumbar spine....
