Spinal Elements said that the FDA has issued 510(K) clearance for the macro-, micro-, and nano-surface structure of its Ti-Bond surface coating technology. The Carlsbad, Calif. company said that a number of products in its portfolio use Ti-Bond, including the most recently introduced Lucent XP height- and lordosis-expandable interbody device.
Interbody fusion products with Ti-Bond technology are comprised of a PEEK body designed to provide a favorable modulus and imaging characteristics while the multi-structured Ti-Bond-coated surfaces are designed to provide a favorable environment at the vertebral endplate, according to the company. Ti-Bond was introduced in 2012.