The system includes an active robot that provides surgeons with fully automated bone preparation and a choice of implant options
The US FDA’s Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
THINK Surgical has secured approval from the US Food and Drug Administration (FDA) for its second-generation TSolution One total knee application system.
The TSolution One system includes an active robot for total knee replacement, which offers surgeons fully automated bone preparation and a choice of implant options.
THINK Surgical’s new system consists of upgrades to the current system, which includes an enhanced pre-surgical planning user interface, quick-change tooling, improved surgeon accessories and advanced bone model generation.
According to the company, the approval of the second-generation TSolution One total knee application comes around one year after its first-generation active robot was cleared.
The system features 3D pre-surgical planning workstation
The TSolution One total knee application system consists of TPLAN, the 3D pre-surgical planning workstation, and TCAT, the active robot that enables the surgeon execute each patient’s individual preoperative plan with consistent results through fully automated bone preparation.
The second-generation robot integrates various changes to the hardware and software, which significantly help to significantly improve the system’s efficiency, flexibility and ease of use while maintaining precision.
THINK Surgical acting CEO Jay Yang said: “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 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.”
In August, THINK Surgical collaborated with United Orthopedic Corporation USA to support the TSolution One total knee application system.
THINK Surgical is involved in the development, manufacturing and marketing of active robotics for hip and knee replacement surgery.