Medacta Gains Regulatory Clearances for NextAR Surgical Planning Applications

By Julie A. Vetalice

Medacta Gains Regulatory Clearances for NextAR Surgical Planning Applications

Medacta received approval under the CE Mark for NextAR™ knee, shoulder and spine applications as part of its NextAR Augmented Reality (AR) surgical platform. Also, the NextAR shoulder application received FDA 510(k) clearance, expanding their U.S. offering from the knee application which received clearance in 2020.

NextAR's smart delivery tools include the single-use NextAR TS tracking system and NextAR Augmented Reality Smart Glasses, and is the first platform to offer Augmented Reality solutions for both spine and joint replacement. NextAR is part of the MySolutions ecosystem of implants and surgical techniques,

CEO Francesco Siccardi said, "With our NextAR Platform we wanted to take another step forward in personalized medicine, improving accuracy in computer-assisted surgery. Efficiency in the operating room is crucial for surgeons and hospitals, and NextAR has the potential to provide significant benefits to healthcare systems around the world. We are proud to have developed an extremely versatile platform, with a single, compact hardware that applies to both joint and spine applications. NextAR perfectly fits in Medacta's vision and in our sophisticated MySolutions personalized ecosystem, focused on delivering advanced personalized solutions that support the surgeon's care of each patient."

Product Labels: Shoulder Replacement, Knee Replacement, Augmented Reality, Spinal Fusion

Tags: 510(k) Clearance, CE Mark, Regulatory