2. February 2023

Naviswiss gains 510k clearance for Naviswiss Knee

Naviswiss gains 510k clearance for Naviswiss Knee, an advanced solution for navigated total knee replacement surgery

Brugg, Switzerland; January 31st, 2023. Naviswiss, a Swiss based medical technology company receives clearance from FDA to market Naviswiss Knee in the United States.

The Naviswiss Knee solution is a landmark-based navigation application and assists the sur-geon in the optimal positioning and alignment of the knee replacement implants. With Naviswiss Knee an orthopedic surgeon can choose between an express workflow with navigated Flexion/Extension and Varus/Valgus alignment only or the Advanced Workflow with additional navigation of Medial and Lateral resection height and Range of Motion overviews.

“Naviswiss Knee is an important addition to our Naviswiss System Platform further expanding our offering for navigated joint replacement”, said Jan Stifter, Naviswiss CEO. “We now have a patient specific option also for total knee replacement where the surgeon determines the best application for the procedure. With Naviswiss Knee we stay tight to our core innovation princi-ples, delivering Smart, Small and Accurate technology to the benefit of all involved in the care chain, not least the patient himself. The addition of our Knee Navigation solution represents a massive opportunity to accelerate Naviswiss’ growth journey.”

Next steps will be a limited market release in the United States with established surgical part-ners. The full launch of Naviswiss Knee Navigation is planned to be rolled out to orthopedic cen-ters across the United States during the latter half of 2023.