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-Bond coating adjacent to bony structures.
FDA agents inspected Spinal Elements’ Carlsbad, Calif. facility in 2014 and the agency issued a warning letter that dubbed the company’s Lucent and Lucent Ti-Bond devices “adulterated” under federal law because the company did not have an approved application for a PMA or an investigational device exemption (IDE) for the devices. The FDA further chided the company for “unsubstantiated claims” made about a “bulleted” Ti-Bond device that the agency never approved, according to the warning letter.
The letter also knocked the company for performance claims regarding a Ti-Bond device, including claims that the implant’s coating “recruits pluri-potential osteogenic cells,” that it helps “minimize implant migration” and that it is “bioactive.”
The agency issued a closeout letter in November 2017, saying Spinal Elements had addressed the violations detailed in the warning letter. The company did not comment on the warning letter, its resolution, or whether the latest clearance was connected to the warning letter.