Titan Spine Receives FDA Clearance to Launch Endoskeleton® TCS Device for Cervical Fusion with Integrated Fixation

MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to commercially release its Endoskeleton® TCS, an interbody fusion device for the cervical spine with integrated fixation.

The Endoskeleton® TCS represents the seventh interbody device in Titan’s portfolio of titanium spinal implant products that collectively addresses approximately 95 percent of the interbody device market. Like the full line of Endoskeleton® implants, the TCS utilizes Titan’s proprietary surface technology designed to participate in the fusion process by creating an osteogenic response to the implant’s topography.

Kevin Gemas, President of Titan Spine, commented, “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. 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 (M/L) and 29 degrees of anterior-posterior (A/P) 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 and MRI imaging, desired bone graft loading, and the ability to pack additional bone graft material within the device following implantation.

Members of the TCS design team include Richard Manos, M.D., Director of Spine Surgery at The Spine Institute of Idaho, Boise, ID; Said Elshihabi, M.D., Director of Neurosurgery at The Wellstar Medical System, Atlanta, GA; and Paul Slosar, M.D., Chief Medical Officer of Titan Spine.

Dr. Manos commented, “I am excited to incorporate the TCS into my practice. I have long believed in the benefits of cervical fusion devices with integrated fixation and feel that the incorporation of osteogenic surface technology is an important innovation in these types of devices. And while it is true that the cervical spine is quite conducive to high fusion rates, the speed in which the patient heals, which begins at the cellular level, can no longer be ignored.”

Dr. Slosar performed the first surgery using the Endoskeleton® TCS on February 9, 2015 at Saint Francis Memorial Hospital in San Francisco, CA. Dr. Slosar remarked, “The surgery went extremely well. 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.”

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 unique combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting the upregulation of osteogenic and angiogenic factors necessary for bone growth, encouraging natural production of bone morphogenetic proteins (BMPs), and creating the potential for a faster and more robust fusion.1,2

About Titan Spine

Titan Spine, LLC is a surface technology company focused on the design and manufacture of interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Titan Spine, located in Mequon, Wisconsin and Laichingen, Germany, markets a full line of Endoskeleton® interbody devices featuring its proprietary textured surface in the U.S. and portions of Europe through its sales force and a network of independent distributors. To learn more, visit www.titanspine.com.

1Olivares-Navarrete, R., Gittens, R.A., Schneider, J.M., Hyzy, S.L., Haithcock, D.A., Ullrich, P.F., Schwartz, Z., Boyan, B.D. (2012). Osteoblasts exhibit a more differentiated phenotype and increased bone morphogenetic production on titanium alloy substrates than poly-ether-ether-ketone. The Spine Journal, 12, 265-272.

2 Olivares-Navarrete, R., Hyzy, S.L., Gittens, R.A., Schneider, J.M., Haithcock, D.A., Ullrich, P.F., Slosar, P. J., Schwartz, Z., Boyan, B.D. (2013). Rough titanium alloys regulate osteoblast production of angiogenic factors. The Spine Journal, 13, 1563-1570.