Mequon, Wisc., devicemaker Titan Spine has received FDA 510(k) clearance for its Endoskeleton line of implants featuring nanoLOCK surface technology, making them the first FDA-approved interbody fusion devices to feature nanotechnology.
Titan’s exclusive nanoLOCK technology increases the amount of nano-scaled textures on the Endoskeleton devices, helping to boost the amount of osteogenic and angiogenic growth factors critical to fusion and bone growth, the company says. This will speed fusion compared with Titan’s current implant surface and other polyetheretherketone implants, the firm adds.
While the manufacturing process creates additional textures at the nano level, the strength of the implant is not changed, Titan says. Neither are there changes to the devices’ indications for use, design, dimensions or materials, according to the company.
The nanoLOCK technology will be applied to all six products in the Endoskeleton line. — Kellen Owings
Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.