Titan Spine has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its Endoskeleton line of interbody fusion implants featuring its next-generation nanoLOCK surface technology. This clearance marks Titan’s line of Endoskeleton spinal implants as the first FDA-approved interbody fusion devices to feature nanotechnology.
Titan’s nanoLOCK surface technology features an increased amount of nano-scaled textures to up-regulate a statistically significant greater amount of the osteogenic and angiogenic growth factors that are critical for bone growth and fusion when compared to PEEK and the company’s current surface.
Barbara Boyan, dean of the School of Engineering at Virginia Commonwealth University and an investigator in various Titan Spine studies, says: “The nanoLOCK surface topography is far different than what is found on titanium-coated PEEK implants. In addition, the nanoLOCK surface is not created by applying a coating, but rather is formed by a reductive process of the titanium itself. This eliminates the potential for delamination, which is a concern for products with a PEEK-titanium interface.”
The nanoLOCK surface is a significant advancement of Titan Spine’s first generation surface. The patented nanoLOCK manufacturing process creates additional textures at the nano level. There are no changes to the device indications for use, design, dimensions, or materials. Additionally, mechanical testing demonstrated that the strength of the company’s line of Endoskeleton implants are unaffected by the new surface treatment.
Paul Slosar, chief medical officer for Titan Spine, comments: “What we have learned is that there are very specific implant surface topographies, especially at the nano level, that generate the osteogenic and angiogenic responses necessary to drive bone growth required for a robust fusion. The nanoLOCK surface is the result of this extensive research and represents the new standard in spinal fusion interbody implants.”
The full line of Endoskeleton devices will feature Titan Spine’s proprietary nanoLOCK implant surface technology, consisting of a unique combination of roughened topographies at the macro, micro, and nano 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.
Titan Spine’s nanoLOCK technology is currently being exhibited at the 2014 North American Spine Society (NASS) Annual Meeting in San Francisco, USA.