Pixee Medical Gets FDA OK for Knee+ NexSight on New AR Platform

Pixee Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Knee+ NexSight, developed on a new augmented reality (AR) platform for total knee arthroplasty (TKA).

Knee+ NexSight was engineered to integrate into high-demand surgical environments like ambulatory surgical centers (ASCs). The next-gen solution boasts technological advancements—it was deployed on a new, more compact AR platform to enhance surgeon comfort, improve efficiency, and increase adaptability in the operating room.

The system purports to offer robotic-level accuracy without the complexity or expense of robotic systems. Its instrumentation is less invasive, can reduce blood loss, and integrates into existing surgical workflows without adding operative time compared to conventional technique, Pixee Medical said.

Knee+ NexSight provides a discreet virtual display in the surgeon’s field of view, along with voice control for a fully hands-free and intuitive surgical experience. It has no disposable components, which allows economic and environmental benefits.

“This solution reflects Pixee Medical’s continued commitment to meeting evolving market needs and providing surgeons with the latest AR technologies that combine robotic-level precision with simplicity of use and cost-efficiency,” the company said in a press release. “Knee+ NexSight is fully compatible with most primary knee implants and personalized surgical approaches, including kinematic alignment.”

The system earned CE mark clearance in February, with its first cases successfully performed in Europe.