Spinal Elements set to launch cervical Ti-Bond-coated implants following FDA approval

187

The US Food and Drug Administration (FDA) has granted Spinal Elements clearance for a full line of interbody devices with Ti-Bond coating for use in the cervical spine.

Spinal Element’s Ti-Bond coating consists of titanium with random, unconnected pores, that is mechanically adhered to the superior and inferior surfaces of its PEEK-OPTIMA interbody implants through a plasma vacuum spray process. This results in a porous titanium bone-opposing surface while allowing for direct visualisation of the fusion mass through the radiolucent PEEK material.

The clearance included the addition of Ti-Bond to the company’s Crystal Cervical Interbody devices as well as their two stand-alone cervical implants–Mosaic and Vertu, a no-profile stand-alone device. The company plans to make the product available starting in the first quarter of 2015.

Jason Blain, president of Spinal Elements, said that he believes “titanium-coated devices will become the standard choice of surgeons in the coming years.”