Pixee Medical receives FDA 510(k) clearance for Knee+ NexSight
Pixee Medical received FDA 510(k) clearance for Knee+ NexSight, its AR solution for U.S. ambulatory surgery centers.
Evidence notes
- The clearance covered a handheld augmented-reality guidance system tailored to total knee arthroplasty in ambulatory surgery centres.
- Knee+ NexSight overlays real-time navigation data in the surgeon’s field of view without requiring a bulky external robot or preoperative CT workflow.
- The platform was designed to work with primary knee implants while keeping the surgeon in direct control of bone-cut and implant-positioning decisions.
Company context
Pixee Medical develops AR surgical navigation systems for orthopedic surgery.