DePuy Synthes receives FDA 510(k) clearance for TriALTIS Spine System

Johnson & Johnson MedTech has announced that DePuy Synthes, the orthopaedics company of Johnson & Johnson, has secured 510(k) clearances from the U.S. Food and Drug Administration (FDA) for the TriALTIS Spine System and for TriALTIS Navigation Enabled Instruments.

The TriALTIS Spine System is a next generation posterior thoracolumbar pedicle screw system that offers a comprehensive implant portfolio and advanced instrumentation designed for integration with enabling technology.

TriALTIS Navigation Enabled Instruments include drills, taps and screwdrivers that can be operated manually or under power for navigated and non-navigated use.

Combining a new portfolio of implants with a digital ecosystem, the TriALTIS Spine System aims to address unmet clinical needs and help surgeons achieve more consistent outcomes in treating complex spine conditions, inclusive of degenerative, tumour, trauma, and deformity pathologies.

Spinal deformity is a prevalent disease with some studies suggesting approximately 32% of adults and as high as 68% of adults over the age of 65 are affected. Age related factors, heterogenous anatomies and complex patient conditions make spinal deformity procedures challenging. As the population ages, spine surgeons are seeing an increasing number of cases with a wide variety of degenerative spinal changes that require instrumented spinal fusion. Surgical treatments of patients with adult spinal deformity have been shown to improve patient outcomes, and significantly improve patient pain, health-related quality of life, and overall treatment satisfaction.

Daniel Sciubba, MD, MBA, chair & professor of neurosurgery at Northwell Health/Hofstra, said: “When it comes to treating complex spinal pathologies, each patient is different, and each case requires its own unique treatment decisions. The TriALTIS Spine System offers a comprehensive implant portfolio that complements different anatomies and procedures and can help to streamline surgical workflows and enable intraoperative flexibility – all with the potential to improve clinical experiences.”

Built on a legacy of reliable thoracolumbar solutions and expertise, the TriALTIS Spine System was developed with a hyper focus on performance and a consistent user experience. The inclusive and forward-looking design philosophy of the TriALTIS Spine System affords smooth integration with cement augmentation, power, navigation, and robotic-assisted solutions.

Russell Powers, worldwide president, spine, DePuy Synthes, said: “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. 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.”