The newly cleared system delivers a precise, repeatable surgical technique to prepare the joint for hip replacement procedures. The process allows the surgeon to select an ideal implant from multiple implant manufacturers after reviewing a detailed CT scan of the patient’s joint. Utilizing the proprietary system software, surgeons for the first time can now preview the surgical outcome before beginning the actual operation.
Dr. Ramesh Trivedi, President and CEO of ROBODOC said, We are very pleased to receive FDA clearance for the ROBODOC System. This milestone represents the first active robotic system cleared by the FDA for orthopaedic surgery allowing our advanced technology to be marketed in US, the largest market in the world for medical devices. We will continue our efforts to further penetrate existing markets where we have met the local regulatory requirements. At the same time we are building an infrastructure to introduce the ROBODOC system to U.S. orthopaedic surgeons, hospitals, and patients.
In 2007, Integrated Surgical Systems with the approval of its shareholders transferred all of its assets to Curexo, Inc. Since the formal clinical studies were started prior to the asset transfer, 510(k) clearance has been received under the name of Integrated Surgical Systems. ROBODOC, a CUREXO Technology Company is making appropriate changes in the registration of the device with U.S. FDA.