FDA Clears New Interbody Fusion Device from Titan Spine

Titain Spine LLC has received 510(k) clearance from the U.S. Food and Drug Administration for its Endoskeleton TCS, an interbody fusion device for the cervical spine with integrated fixation.

The Endoskeleton TCS is the seventh interbody device in Titan’s portfolio of titanium spinal implant products. Like the full line of Endoskeleton implants, the TCS uses Titan’s proprietary surface technology designed to participate in the fusion process by creating an osteogenic response to the implant’s topography.

“We are proud to launch the Endoskeleton TCS as the latest addition to our surface engineered interbody device portfolio that continues to challenge the status quo in the interbody fusion marketplace,” said Presdient Kevin Gemas. “Like the rest of our products, the TCS is designed to benefit patients by affecting their healing process where it matters most—at the cellular level. The roughened surface technology featured on the TCS is created through a proprietary process that has been shown to produce a superior environment for bone growth at the cellular level when compared to PEEK. In addition, it has several advantages compared to PEEK devices with titanium plasma spray (TPS) coated devices. Most importantly, our surface is created through a proprietary subtractive process rather than an additive coating, which eliminates the potential for delamination and/or particulate debris when compared to products with a PEEK-titanium interface.”

The Endoskeleton TCS device is designed for integrated fixation with two surface-enhanced screws that provide for immediate implant mechanical stability. The screws incorporate an anti-backout feature that do not lock the screws to the implant and allow up to 39 degrees of medial-lateral and 29 degrees of anterior-posterior angulation post-implantation. The design of the TCS is consistent with the rest of the company’s interbody device portfolio by allowing for endplate sparing and apophyseal fixation and the incorporation of large windows and large internal volumes to allow for significant bone graft packing, clear CT (computed tomography) and MRI (magnetic resonance iomaging), desired bone graft loading, and the ability to pack additional bone graft material within the device following implantation.

Paul Slosar, M.D., who was also part of the device design team, performed the first surgery using the Endoskeleton TCS on February 9 at Saint Francis Memorial Hospital in San Francisco, Calif.

“The surgery went extremely well,” Slosar reported. “The instrumentation was intuitive and easily allowed me to place the implant and screws exactly as intended. I was particularly pleased with the stability of the implant’s macro surface to prevent device movement during screw insertion. The TCS is a perfect complement to Titan’s robust and growing pipeline.”

Titan Spine, a medical device surface technology company focused on spinal interbody fusion implants, is headquartered in Mequon, Wis.