Interbody Fusion Device FDA-Cleared

The FDA has granted 510(k) clearance to a spinal fusion device made by Wisconsin-based Titan Spine.

The newly cleared device is the Endoskeleton TCS, an interbody fusion device for the cervical spine with integrated fixation. It is the seventh interbody device in the product line, which already collectively addresses 95 percent of the interbody fusion device market. The devices are made of titanium and have a proprietary surface technology designed to encourage bone growth.

Other design features include surface-enhanced screws that provide for immediate implant mechanical stability and large internal volumes to allow for bone growth packing and clear MRI imaging.

Paul Slosar, chief medical officer of Titan Spine, performed the first surgery using the device Feb. 9 at St. Francis Memorial Hospital in San Francisco. — Elizabeth Orr