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 nanoLOCK surface technology. This clearance marks Titan’s line of Endoskeleton spinal implants as the first FDA-cleared interbody fusion devices to feature nanotechnology. The nanoLOCK surface will be commercialised in mid to late-2015.
Titan Spine says that the nanoLOCK surface technology enhances the company’s line of Endoskeleton devices with 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.
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 patented nanoLOCK manufacturing process creates additional textures at the critical nano-level. However, the company stresses that 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.”