The US Food and Drug Administration (FDA) has approved claims related to the macro-, micro-, and nano-surface structure of Spinal Elements' Ti-Bond surface coating technology.
Image: Spinal Elements' Lucent XP Expandable Lumbar Interbody System. Photo: Courtesy of Business Wire.
The portfolio of Spinal Elements includes several products featuring Ti-Bond, including the Lucent XP height- and lordosis- expandable interbody device.
Interbody fusion products that feature Ti-Bond technology consist of a PEEK body which offers favorable modulus and imaging characteristics surgeons surgeons have come to trust.
The multi-structured Ti-Bond-coated surfaces are designed to provide a favorable environment at the vertebral endplate.
Products featuring the Ti-Bond surface coating technology are claimed to benefit several patients since its initial introduction in 2012.
Ti-Bond allows spine surgeons to have the latest technology without compromising on imaging characteristics, spinal loading conditions, or long-term performance.
The clearance from FDA is an indication that complex surface environment provided by Ti-Bond coating adjacent to boney structures.
Spinal Elements president and CEO Jason Blain said: “Spinal Elements has had a long, successful experience with the clinical application of Ti-Bond technology in the spine.
“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.”
In May this year, Spinal Elements announced the expanded commercial release of its Clutch interspinous process device, which is claimed to enhance the breadth of the company’s thoracolumbar portfolio and offers surgeons more options for treating various posterior thoracolumbar pathologies.
Clutch was in use, since shortly after securing FDA clearance last year and the expanded release is expected to set new standard. It features a spring-activated mechanism, designed to maintain active compression against the spinous processes to resist loosening and migration.
The device’s bone opposing surfaces are enhanced with clinically proven Ti-Bond technology, designed to provide immediate stability and long-term fixation.
Headquartered in Carlsbad, California, Spinal Elements is a designer, developer and manufacturer of medical devices used in spinal surgical procedures.
The company aims to combine medical device technologies, biologics and instrumentation to create positive surgical outcomes that exceed the expectations of surgeons and patients.