FDA Clears Spinal Fusion System from Titan Spine

Titan Spine LLC, a medical device surface technology company focused on developing spinal interbody fusion implants, received clearance from the U.S. Food and Drug Administration (FDA) for its Endoskeleton TL system, a spinal fusion system using a lateral approach. According to the company, the Endoskeleton TL represents the first lateral fusion device to feature surface technology that is designed to participate in the fusion process by creating an osteogenic response to the implant’s topography.

The device uses Titan’s proprietary roughened titanium surface technology, which has been shown to upregulate the production of osteogenic (bone growth) and angiogenic (formation of new blood vessels) factors that are critical for bone growth and fusion.

The design of the TL device incorporates large windows and large internal volumes to allow for significant bone graft packing, clear CT and MRI imaging, desired bone graft loading, and the ability to pack additional bone graft material within the device following implantation, according to the company.

Members of the TL design team include Kade Huntsman, M.D., orthopedic spine surgeon with the Salt Lake Orthopaedic Clinic in Salt Lake City, Utah; Andy Kranenburg, M.D., co-medical director of the Providence Medford Medical Center Spine Institute in Medford, Ore.; Axel Reinhardt, M.D., head of the Department of Spinal Surgery at the Specialized Orthopaedic Hospital in Potsdam, Germany; and Paul Slosar, M.D., chief medical officer for Titan Spine.

Huntsman performed the first surgeries using the Endoskeleton TL on July 9 at St. Mark’s Hospital in Salt Lake City.

“I was extremely pleased with the performance of the system. For the first time, I was able to insert additional bone graft material in to a lateral device post-implantation, and the radiopaque nature of the TL made it extremely easy to place the device in the desired location,” he said. “I am excited to offer the TL, and the benefits of its surface technology and design features, to my patients requiring lateral interbody fusion.”

Slosar noted: “The ability to orchestrate cellular behavior and promote bone growth in response to an interbody device has not been in the lateral surgeon’s armamentarium until now. The TL is the byproduct of a unique collaboration between academic biomaterial scientists, spine surgeons, and industry experts to create a truly differentiated lateral interbody device that is designed to benefit both patients and surgeons. With the addition of the TL device, Titan Spine now offers its surface technology and complete line of titanium devices for virtually all interbody fusion spine surgery procedures in the cervical and lumbar spine.”

The full line of Endoskeleton devices features Titan Spine’s proprietary implant surface technology, consisting of a unique combination of roughened topographies at the macro, micro, and cellular levels. This combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting new bone growth, encouraging natural production of bone morphogenetic proteins and creating the potential for a faster and more robust fusion.