FDA clears Spinal Elements ’ surface coating technology

Spinal Elements’ Lucent XP expandable lumbar interbody system with Ti-Bond coating. (Image courtesy of Spinal Elements) 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. “Spinal Elements has had a long, successful experience with the clinical application of Ti-Bond technology in the spine,” said Jason Blain, president & CEO of Spinal Elements, in a prepared statement. “This FDA clearance represents an important scientific element of the overall Ti-Bond story – one that will expand even more as the platform continues to flourish, and we provide an increasing number of technology-based solutions to improve patient outcomes.” Ti-Bond does not compromise imaging characteristics, spinal loading conditions, or long-term performance, the company added, saying that the FDA clearance further demonstrates the complex surface environment provided by Ti...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog Food & Drug Administration (FDA) Implants Orthopedics Spinal Spinal Elements Source Type: news