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FDA 510(k) Clearance Granted to TMINI Miniature Robotic System by THINK Surgical

Wednesday, May 31, 2023

THINK Surgical, a renowned innovator in orthopedic surgical robots, announced today that its TMINI Miniature Robotic System has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA). The TMINI system features a wireless robotic handpiece designed to assist surgeons in performing total knee replacement surgeries. Using a CT-based three-dimensional surgical plan, the TMINI robotic handpiece compensates for surgeon hand movement, precisely locating bone pins along predefined planes. Subsequently, cutting guides are attached to the bone pins for accurate bone resection. The TMINI system is user-friendly and replaces several instruments typically used in knee replacement surgery.

THINK Surgical is committed to maintaining an open implant library and plans to continuously add new implant options to the platform. This open approach, combined with the TMINI system's ease of use, is expected to appeal to a wide range of customers who may have previously been hesitant about adopting robotic technology.

The TMINI robotic handpiece was developed in collaboration with Sagentia Innovation, an R&D consultancy based in Cambridge, U.K. The collective technical expertise of both companies facilitated the innovative design of the TMINI robotic handpiece, seamlessly integrating it into operating room workflows for surgeons and staff.

Stuart Simpson, President and CEO of THINK Surgical, expressed enthusiasm about the TMINI system's potential, stating, "With its compact size, open implant platform, and intuitive workflow, the TMINI system unlocks robotic possibilities for more clinics, operating rooms, and surgeons." Duncan Smith, Managing Partner of Sagentia Innovation, shared his excitement, saying, "We are thrilled to have supported this project from its early concept development to manufacturing, and we look forward to its commercial success."



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