Pixee Medical Gains FDA Clearance for Novel Knee+ NexSight AR System
Pixee Medical has received U.S. FDA 510(k) clearance for Knee+ NexSight, its next-generation augmented reality navigation system for total knee arthroplasty (TKA).
The solution is built on a new AR platform designed to improve surgical precision while simplifying workflow in operating rooms.
The clearance strengthens the company's position in the growing U.S. orthopaedic market, particularly in ambulatory surgical centres, where efficiency, ease of use and cost management are important priorities.
Developed on a more compact AR platform, Knee+ NexSight is designed to enhance surgeon comfort, improve operating room efficiency and remain fully compatible with surgical hoods.
The system delivers robotic-level accuracy without the cost and complexity associated with robotic surgical platforms.
Its less invasive instrumentation may help reduce blood loss and integrate into existing surgical workflows without increasing procedure time.
Knee+ NexSight features a virtual display within the surgeon’s field of view and voice-control capabilities, enabling a hands-free surgical experience. The absence of disposable components also supports cost savings and environmental sustainability.
The solution is compatible with most primary knee implants and personalised surgical techniques, including kinematic alignment.
Knee+ NexSight previously received CE Mark approval in February 2026, and initial procedures have already been successfully performed in Europe.
