Think Surgical said yesterday that it won 510(k) clearance from the FDA for its TSolution One robot-assisted total knee replacement device.
The TSolution One system uses Fremont, Calif.-based Think Surgical’s 3D pre-surgical planning workstation and computer-assisted Active robot. It won CE Mark approval in the European Union for total knees in December 2017.
“We are thrilled to expand the use of this state-of-the-art technology, which is truly transforming orthopedic surgery,” president & CEO John Hahn said in prepared remarks. “U.S. FDA clearance of TSolution One furthers our commitment to improving the lives of patients suffering from severe osteoarthritis by expanding the global commercialization of our active robot for TKA. 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.”
“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,” added Dr. Bernard Stulberg, who was principal investigator in the 115-patient study used to back Think Surgical’s FDA bid. “This innovative system will revolutionize the treatment of end-stage knee arthritis by coupling an individualized plan with precise bone cutting technology.”
Think Surgical said TSolution One has been used in more than 550 total knee procedures to date. The company reported raising more than $134 million in a debt-and-securities round in March.