Titan Spine announced that it 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.
The nanoLOCK technology will be highlighted at the 2014 North American Spine Society (NASS) Annual Meeting, being held November 12-15, 2014 in San Francisco, California.
Titan's new nanoLOCKTM 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 and fusion when compared to PEEK1 and the company's current surface.
Titan's nanoLOCK surface is a significant advancement of the company's first-generation surface. The patented nanoLOCK manufacturing process creates additional textures at the critical nano level. However, 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, M.D., Chief Medical Officer for Titan Spine, commented, "Our new surface technology represents a significant technological breakthrough in treating patients that require interbody fusion. 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 nanoLOCKTM surface is the result of this extensive research and represents the new standard in spinal fusion interbody implants. Titan Spine will offer its complete line of titanium devices for interbody fusion spine surgery procedures in the cervical and lumbar spine now with nano-scale features that offer added benefits to patients."
The full line of Endoskeleton devices will feature Titan Spine's proprietary nanoLOCKTM implant surface technology, consisting of a unique combination of roughened topographies at the macro, micro, and nano levels.