Medacta Gains FDA Clearance for Augmented Reality Knee Platform

By Julie A. Vetalice

Medacta Gains FDA Clearance for Augmented Reality Knee Platform

Medacta received FDA clearance to market its NextAR™ Augmented Reality based surgical platform for total knee arthroplasty (TKA).

NextAR TKA, which works with the Medacta GMK Sphere Medially Stabilized Knee, is the first application of a new platform technology which will be extended to hip, shoulder and spine, and is designed with Artificial Intelligence and Machine Learning to add efficiency and precision to pre-operative CT-based planning and analysis.

Single-use NextAR TKA requires a low upfront capital investment from clinics and hospitals, and is appropriate for use in ambulatory surgical centers. Augmented Reality glasses allow the surgeon to visualize surgical actions and information in real-time, directly on the operative field, to retain patient focus and track 3D soft tissue behavior during a surgery in real time.

In addition to planning tools, Medacta has developed NextAR TS, an infrared single-use tracking system that can enhance surgical efficiency and support execution of pre-op plans.

Francesco Siccardi, CEO of Medacta, said, "Patients and surgeons are attracted by improved outcomes and innovation, the NextAR Platform is one Medacta answer to the current race in orthopaedic technology and I am very excited about this milestone achievement. Requiring a very limited investment in capital equipment, the NextAR Platform perfectly represents Medacta's commitment to develop solutions that are able to improve patient outcomes and healthcare system sustainability."

Product Labels: Augmented Reality, Surgical Planning

Tags: 510(k) Clearance, Regulatory