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FDA Approves Think Surgical’s Second-Gen Robotic Knee Surgery System

Think Surgical announced today that FDA has granted 510(k) clearance for the second generation of its TSolution One total knee replacement system. The system features an active robot for total knee replacement, providing fully automated bone preparation, and gives surgeons a choice of implant options.

The new total knee replacement system features upgrades to the current system, including an enhanced pre-surgical planning user interface, quick-change tooling, improved surgeon accessories, and advanced bone model generation.

The clearance of the second-generation TSolution One total knee replacement system comes approximately one year after THINK’s first-generation active robot was cleared.

“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.”

Robot-assisted surgery is currently a hot area in medical technology
Robot-assisted surgery is currently a hot area in medical technology.

The TSolution One total Knee Application is comprised of TPLAN, the 3D pre-surgical planning workstation, and TCAT, the active robot that helps the surgeon execute each patient’s individual preoperative plan with consistent results through fully automated bone preparation. This second-generation robot incorporates several changes to the hardware and software, which significantly enhance the system’s efficiency, flexibility and ease of use while maintaining the precision and innovation that is the hallmark of the TSolution One Total Knee Application system.

In other healthcare robotics news, Johnson & Johnson (J&J) yesterday shared details about its new Ottava surgical robotic platform. The Ottava system has six arms to provide more control and flexibility in surgery, while its arms will be integrated into the operating table.

J&J claimed Ottava has a zero-footprint design to enable patient access, increase space in the operating room, and improve workflow. J&J acquired Auris Health in 2019 for $3.4 billion and brought on Dr. Fred Moll as its chief development officer.

Robot-assisted surgery is currently a hot area in medical technology, with J&J, Medtronic and others seeking to take on Intuitive Surgical, whose da Vinci robot is the market leader. J&J claimed that Ottava will offer more flexibility than any currently available system.

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