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.”