The FDA has cleared a robotic system that seems to follow the "practice makes perfect" school of thought. The DidiMatch Robodoc allows orthopedic surgeons to perform a hip replacement procedure virtually, using a 3-D bone image created from a CT scan of the patient's anatomy, before beginning the actual operation.
Robodoc (Sacramento, California), a Curexo Technology company, said it received 510(k) clearance for the system under the name of its predecessor, Integrated Surgical Systems (ISS; also Sacramento). The system is designed to reduce surgical fractures and complications and minimize human error.
"It's not just interesting, it's phenomenally interesting," Ramesh Trivedi, PhD, president/CEO of Robodoc, told Medical Device Daily.
According to the company, the Robodoc 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.
The robotic system includes two components: Orthodoc, a computer workstation equipped with software for 3-D preoperative surgical planning, and the Robodoc Surgical Assistant, a computer-controlled surgical robot used for precise cavity and surface preparation for hip and knee replacement surgeries. The system made medical history in 1992 as the first robot assisting in a human total hip replacement, the company noted.
Trivedi said the system is different from other robotic surgical systems in that the robot is actively involved in the operation. Other systems, such as the da Vinci system from Intuitive Surgical (Sunnyvale, California), are computer-assisted devices and the surgeon holds onto the robot arm like a joystick and is "driving" the operation. With the Robodoc system, the surgeon plans the operation, the plan is transferred to the robot, and once the surgeon makes the incision during the actual operation the robot proceeds with the rest of the surgery. That's why the company calls this system an "active robot," he said.
The main concerns the FDA had before clearing the device was whether or not it was safe, given the fact that it is computer-controlled, Trivedi said. "That is why it took us quite some time to go over FDA's concerns," he said.
Shelia Shah, a company spokeswoman, told MDD that the Robodoc system is being used in other countries for knee procedures, as well as hip procedures, but that in the U.S. it is only cleared for use in hip surgeries. The company hopes the device will eventually be cleared in the U.S. for knee procedures as well as hip surgeries, she said.
The robotic assistant has been used in more than 24,000 joint replacement procedures worldwide, Robodoc said, and is shown to be less traumatic for patients and more precise than manual preparation techniques. In total hip surgery applications the Robodoc system executes exact bone cutting and precise implant placement to reduce surgical fractures and complications and minimize human error.
"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 the U.S., the largest market in the world for medical devices," said Trivedi. "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. orthopedic surgeons, hospitals and patients."
Last year ISS transferred all of its assets to Curexo. Because the formal clinical studies were started before the asset transfer, FDA clearance was given under the ISS name. Robodoc said it is making appropriate changes in the registration of the device with the agency.