Spinal Elements announces FDA clearance of Ti-Bond titanium coating as a macro-, micro-, and nano-surface

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Spinal Elements’ Lucent XP Expandable Lumbar Interbody System

Spinal Elements has recently announced FDA clearance for claims related to the macro-, micro-, and nano-surface structure of its Ti-Bond surface coating technology. Utilising this advancement, the company have recently introduced the Lucent XP height- and lordosis- expandable interbody device.

Interbody fusion products featuring Ti-Bond technology are comprised of a PEEK body which provides the favourable modulus and imaging characteristics surgeons have come to trust while the multi-structured Ti-Bond-coated surfaces are designed to provide a favourable environment at the vertebral endplate. Since its initial introduction in 2012, products featuring the Ti-Bond surface coating technology have been applied in tens of thousands of procedures.

“Spinal Elements has had a long, successful experience with the clinical application of Ti-Bond technology in the spine,” stated Jason Blain, president and CEO of Spinal Elements. “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 was an important addition to the spine fusion market. Since its introduction, other technologies have emerged, each with their own compromises when considered for fusion. Ti-Bond allows the spine surgeon to have the latest technology without compromising imaging characteristics, spinal loading conditions, or long-term performance. This clearance demonstrates the complex surface environment provided by Ti-Bond coating adjacent to bony structures.

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