BY SEAN WHOOLEY

[Image courtesy of DePuy Synthes]

Johnson & Johnson MedTech announced today that its DePuy Synthes unit won FDA 510(k) clearance for two TriAltis technologies.
The FDA cleared the company’s TriAltis Spine system and the TriAltis navigation-enabled instruments. TriAltis Spine is a next-generation posterior thoracolumbar pedicle screw system. It offers a comprehensive implant portfolio and advanced instrumentation for integration with enabling technology.
DePuy Synthes’ TriAltis navigation-enabled instruments include drills, taps and screwdrivers. These offer manual operation or power operation for navigated and non-navigated use.
The company said combining its implants with a digital ecosystem can address unmet clinical needs. Its TriAltis Spine system could help surgeons achieve more consistent outcomes in treating complex spine conditions, too. That includes degenerative tumor, trauma and deformity pathologies.
DePuy Synthes built its TriAltis system on what it calls a legacy of thoracolumbar solutions and expertise. It features a “hyperfocus” on performance and a consistent user experience. Its design provides smooth integration with cement augmentation, power, navigation and robotic-assisted solutions.
The company expects to make the TriAltis Spine system available in the U.S. in 2024.
“The TriAltis Spine system will be our premier pedicle screw platform designed to work seamlessly across our entire DePuy Synthes portfolio of enabling technology solutions,” said Russell Powers, worldwide president, spine, DePuy Synthes. “Johnson & Johnson MedTech is proud to deliver this exciting innovation that can help facilitate the surgical treatment of spinal degeneration and deformity with the goal to improve fixation, drive better patient outcomes and potentially reduce the clinical and economic burden associated with the current standard of care.
“DePuy Synthes has been a leader in the complex spine space for over 35 years, and the launch of the TriAltis Spine system will mark a critical milestone towards our vision to continue this legacy long into the future.”