Flexuspine out of Pittsburgh, PA has received FDA conditional approval for a feasibility study of its FSU (Functional Spine Unit) under the Investigational Device Exemption (IDE). The Total Spine Arthroplasty system has two components: a cobalt-chrome interbody core and a posterior dynamic resistance dampener. It is designed to restore the motion and natural kinematics of the affected vertebra, and to provide an alternative to spinal fusion. The study will enroll spinal fusion candidates with Degenerative Disc Disease and facet compromise.
From the product page:
The unique Cobalt Chrome (CoCr) metal-on-metal articulating design features two paired halves, which facilitate placement on each side of the dural sac intended to allow ample endplate coverage and natural kinematic motion. The Core is the foundational support for the FSU device. It features strength in compression while providing shear resistance intended to prevent overloading of the posterior dampening component. The combination of converging inferior endplate anchors, teeth on the superior surface, and Titanium Plasma Spray (TPS) coating was designed to resist migration and provide short and long-term fixation.
Dampener System design:
The Posterior Dampener component includes a CoCr alloy pedicle screw and sliding rod assembly with silicone dampeners. The rod and screw assemblies are implanted bilaterally after facet removal. The silicone dampeners are designed to provide resistance to flexion-extension, lateral bending, and axial rotation motions. Dual silicone dampeners and sliding rod design provide physiological resistance (non-linear and direction-specific stiffness) which allows for some forgiveness in the alignment of the Dampeners to the Core component.
Press release: Flexuspine receives FDA conditional approval to begin a feasibility study of its FSU system…
Product page: Functional Spinal Unit…