Titan Spine receives FDA clearance for new surface technology

Titan Spine announced it has received 510(k) clearance from the U.S. Food and Drug Administration to market its Endoskeleton line of interbody fusion implants featuring its nanoLOCK surface technology.

The clearance marks the first line of FDA-approved interbody fusion devices to feature nanotechnology, according to a company press release.

The new surface technology enhances the company’s line of Endoskeleton devices with an increased number of nano-scaled textures to up-regulate a statistically significantly greater number of the osteogenic and angiogenic growth factors critical for bone growth and fusion compared with PEEK and the company’s current surface, according to the release.

Although the nanoLock manufacturing process creates additional textures at the critical nano level, the company reported no changes have been made to the device’s indications for use, design, dimensions or materials, nor has the device’s strength been affected.

Reference: www.titanspine.com.

Titan Spine announced it has received 510(k) clearance from the U.S. Food and Drug Administration to market its Endoskeleton line of interbody fusion implants featuring its nanoLOCK surface technology.

The clearance marks the first line of FDA-approved interbody fusion devices to feature nanotechnology, according to a company press release.

The new surface technology enhances the company’s line of Endoskeleton devices with an increased number of nano-scaled textures to up-regulate a statistically significantly greater number of the osteogenic and angiogenic growth factors critical for bone growth and fusion compared with PEEK and the company’s current surface, according to the release.

Although the nanoLock manufacturing process creates additional textures at the critical nano level, the company reported no changes have been made to the device’s indications for use, design, dimensions or materials, nor has the device’s strength been affected.

Reference: www.titanspine.com.