The 510(k) application is used when there exist similar, previously cleared technologies in the marketplace. This submission follows the company’s recently cleared 510(k) for total hip arthroplasty and will offer surgeons an accurate, precise and reproducible surgical technique to prepare the joint during a knee replacement procedure, said Curexo.
According to the company, the process will allow surgeons to preoperatively plan their surgery in a 3D virtual space and then execute the surgery exactly as planned in the operating theater.
Brent Mittelstadt, president and CEO of Curexo, said: “We believe that because of our recent hip application clearance, receiving the total knee arthroplasty market clearance should be granted within a reasonable time frame. Offering this additional application will allow us to build upon relationships that we are establishing as we introduce the Robodoc surgical system into the US orthopedic community.”