FDA Clears Titanium-Coated Implants From Spinal Elements

Spinal Elements has received U.S. Food and Drug Administration clearance for a full line of cervical spinal devices coated with titanium.

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

The clearance included the addition of Ti-Bond to the company’s Crystal Cervical Interbody devices as well as 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.

“We are glad to be able to expand our interbody offering to include Ti-Bond on devices for use in the cervical spine,” said Jason Blain, president of Spinal Elements. “We believe titanium-coated devices will become the standard choice of surgeons in the coming years. This product introduction will join the MIS solutions that we will be introducing in 2015.”

Spinal Elements first introduced Ti-Bond in its lumbar products in 2012. The company has a full compliment of lumbar Ti-Bond coated devices, including posterior lumbar interbody fusion, transforaminal lumbar interbody fusion, and anterior lumbar interbody fusion devices. The company additionally has clearance for Ti-Bond on laterally-placed implants and will begin introducing that platform later in the year as it expands its minimally invasive surgical solutions.

“This clearance and launch further establish Spinal Elements’ lead in the advancement of new technologies and materials in the interbody spinal fusion space, and will help fuel the excitement and growth we have seen related to our Ti-Bond devices,” Spinal Elements CEOTodd Andres said.

Headquartered in Carlsbad, Calif., Spinal Elements is a spine technology company focused on the development and marketing of progressive spinal treatment options.