Titan Spine received 510(k) clearance from the U.S. Food and Drug Administration to market its Endoskeleton line of interbody fusion implants, which features its next-generation nanoLOCK surface technology.
The clearance marks Titan's line of Endoskeleton spinal implants as the first FDA-approved interbody fusion devices to feature nanotechnology. The company's patented nanoLOCK manufacturing process creates additional textures at the critical nano level. The full line of Endoskeleton devices will feature the nanoLOCK implant surface technology.
"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 nanoLOCK 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," said Paul Slosar, MD, CMO of Titan Spine.
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