FDA Approves Robotic Knee Surgery Platform

The US Food and Drug Administration (FDA) has cleared the marketing for TSolution One Total Knee Application, a fully active robot, for use in total knee arthroplasty (TKA).

The clearance, which proceeds marketing indications among Asia Pacific and European regulators, included a computed tomography (CT)-based 3D planning software which allows surgeons to virtually design and prepare a patient’s knee joint replacement surgery—before the robot prepares the surgeon’s plan for precise knee implant placement.

A clinical trial which evidenced the safety and efficacy of the software platform and robot was completed in December 2018. It included 115 patients and 5 participating surgeons.

Among the surgeons was William J. Long, MD, an orthopedic surgeon at NYU Langone. Earlier this year, MD Magazine® spoke with Long’s colleague Claudette Lajam, MD, a fellow orthopedic surgeon with NYU Langone.

Lajam spoke on both the potential and limitations of robot-assisted surgery—noting that while the software may help avoid errors and improve pre-surgery strategy, its benefit in the procedure and post-operative cases is minimal.

“That robot doesn't have the kind of feedback that a surgeon has,” Lajam said. “And it also doesn't see the patient postoperatively and understand, well what you do in here is going to turn into something else a year from now.”

Looking forward to a future of advanced surgical technology including robotics, navigation, and virtual reality, Lajam called for colleagues to embrace the responsibility of learning and understanding these new tools.

One surgeon involved in the clinical trials, principal investigator Bernard Stulberg, MD, of the Cleveland Clinic, emphasized the device’s addition to personalized care measures in the field.

"What will be particularly appealing to surgeons is the open implant library offered by this active robotic system, which can achieve an optimal personalized surgical plan for each patient," Stulberg said in a statement. "This innovative system will revolutionize the treatment of end-stage knee arthritis by coupling an individualized plan with precise bone cutting technology."

John Hahn, chief executive officer and president of ownership company THINK Surgical, expressed thrill for the clearance of new technology which he believes is “truly transforming orthopedic surgery.”

“This significant achievement is a testament to our team's dedication, and I am grateful for their hard work in making this vision a reality,” he said.