Think Surgical announced today that FDA has granted 510(k) clearance for the second generation of its TSolution One total knee application.
The TSolution One is an active robot for total knee replacement; it includes fully automated bone preparation and provides surgeons a choice of implant options. The newly-cleared version of the system features includes an enhanced pre-surgical planning user interface, quick-change tooling, improved surgeon accessories, and advanced bone model generation, according to Think Surgical..
FDA cleared the first generation of the robot more than a year ago.
“The ongoing evolution of the TSolution One total knee application is a testament to Think Surgical’s dedication and investment in advancing the use of robot technology in the orthopedic setting,” the company’s acting CEO Jay Yang said in a news release. “The versatile, open platform provides surgeons with the flexibility of using a variety of implants, while offering hospitals and ambulatory surgery centers a sustainable, high throughput system for their ever-increasing total knee replacement procedures.”