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Home » FDA clears Think Surgical handheld robotic knee surgery device

FDA clears Think Surgical handheld robotic knee surgery device

May 30, 2023 By Chris Newmarker

Think Surgical marketing image of its TMINI handheld ortho surgical robot
The TMINI miniature robotic system for total knee surgeries [Image courtesy of Think Surgical]
Think Surgical announced today that it’s received FDA 510(k) clearance for its TMINI miniature robotic system that assists with total knee surgeries.

Here’s how Fremont, California–based Think Surgical described the TMINI system in its news release:

“The TMINI system includes a wireless robotic handpiece that assists surgeons in performing total knee replacement. Following a CT-based three-dimensional surgical plan, the TMINI robotic handpiece automatically compensates for surgeon hand movement to locate bone pins along precisely defined planes. Cutting guides are then connected to the bone pins for accurate bone resection. TMINI is easy to use and replaces many of the instruments currently used for knee replacement surgery.”

For comparison, Stryker’s popular Mako system is more about creating a patient-specific preoperative plan off of a CT scan that is then uploaded to the robot. The Mako system then assists the surgeon with performing the cuts. The surgeon actually pushes the saw, but the robot limits where the saw can go in space. (Read more in this Medical Design & Outsourcing article from 2019.)

And unlike many companies in the robotic ortho surgery space that have an assortment of their own implants that go along with their systems, Think Surgical said it is committed to an open implant library. It will continue to add new implant options to the platform over time. Company officials are betting that the strategy will appeal to a broad customer base that may have been resistant to robotics until now.

“With its small footprint, open implant platform and intuitive workflow, the TMINI system opens up robotic possibilities for more clinics, operating rooms, and surgeons,” said Think Surgical CEO Stuart Simpson.

Cambridge, U.K.–based Sagentia Innovation assisted Think Surgical on the TMINI system design. Said Sagentia Innovation managing partner Duncan Smith: “The broader market opportunity for the TMINI system makes this an important development in surgical robotics. It’s been exciting supporting this project from early concept development through transfer-to-manufacture, and we look forward to its commercial success.”

Filed Under: 510(k), Featured, Food & Drug Administration (FDA), News Well, Orthopedics, Regulatory/Compliance, Surgical, Surgical Robotics Tagged With: robot-assisted, Robotic Surgery, Sagentia Innovation, Think Surgical

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About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at [email protected].

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