OnPoint Surgical Receives FDA Approval for the OnPoint Augmented Reality Spine System

OnPoint Surgical has received the US Food and Drug Administration (FDA) 510(k) Clearance for its OnPoint Augmented Reality Spine System, which superimposes virtual surgical guides and virtual implants onto the surgeon’s visual field using proprietary see-through optical head-mounted display technology.

Surgeons provided with the device for experimental use have been highly enthusiastic about the technology, finding it intuitive and easy to use.

The OnPoint AR Spine System is open platform and compatible with the implants of major manufacturers; it requires no change in surgical technique or surgeon practice. The OnPoint AR Spine System platform technology is a cost-effective and highly accurate alternative to current robotic systems. The system is readily implemented in hospital settings and also well suited for ambulatory surgery centers (ASC’s) in view of its small footprint. The head mounted display is 4-10x lighter and has 2-4x greater resolution than existing AR systems for spinal procedures.

These benefits are enhanced by unprecedented accuracy, with cadaver studies showing the OnPoint Augmented Reality Spine System exceeding that of all major existing navigation, robotic and augmented reality systems between 2 – 5x, with the differences being statistically highly significant across all comparisons (data accepted for presentation at the 2023 Congress of Neurological Surgeons, Sept. 9 – 13, 2023, Washington, D.C.).

“We are pleased with the 510(k) clearance which will allow the OnPoint Augmented Reality Spine System to be made available for excellence in clinical care nationwide.”, stated Philipp Lang, CEO and Chairman.

“Having used the OnPoint AR Spine System on several occasions during its development, I am deeply impressed by its unique accuracy, easy to use interface, and the clarity of the information presented. I believe that the benefit of this system will be in improving outcomes after surgery, increasing the safety of the surgery, the speed of the surgery, and our confidence that all of our implants are in an optimal position for every patient. We are thrilled to offer this unique technology to our patients in the near future.”, stated Dr. Michael Groff, Vice Chair of Neurosurgery, Director of Spinal Neurosurgery, Co-Director Comprehensive Spine Surgery, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA.