THINK Surgical, based in Fremont, California, has announced that its TMINI Miniature Robotic System (TMINI 1.1) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The clearance allows the company to market the updated system, which offers enhanced capabilities for total knee arthroplasty procedures.
The TMINI 1.1 system introduces the TMINI PRO workflow, which includes features for positional refinement and optimization of implants tailored to individual patient needs. This workflow provides dynamic data capture and real-time feedback, enabling surgeons to make adjustments to implant positioning and stability during surgery. The system is designed to be intuitive and customizable to suit surgeon preferences and implant philosophies. Adjustments to the surgical plan are transmitted wirelessly to the TMINI robot, facilitating a seamless surgical experience.
Dr. Alexander Sah, Co-Director of the Institute of Joint Restoration, highlighted the benefits of the TMINI PRO workflow, particularly the ability to assess real-time soft tissue balance and adjust surgical plans intraoperatively to improve patient outcomes.
The TMINI System includes a wireless robotic handpiece that aids in total knee replacement surgeries. Using a CT-based three-dimensional surgical plan, which can be updated based on intraoperative assessments, the robotic handpiece compensates for surgeon hand movement to accurately place bone pins. Cutting guides are then attached to these pins for precise bone resection. The system aims to replace many of the traditional instruments used in manual knee replacement surgeries.
Stuart Simpson, President and CEO of THINK Surgical, remarked on the significance of the FDA clearance, noting that it underscores the company’s development capabilities and commitment to innovation in the field of robotics and digital surgery. This is the second FDA clearance for the TMINI System within 15 months.
THINK Surgical is focused on broadening access to its TMINI system, catering to customers who prefer either an open platform, which allows for a variety of implants, or an exclusive platform, which offers access to the robot in exchange for loyalty to a single implant brand. The company plans to expand its open implant library, aiming to attract a wide customer base that may have been hesitant to adopt robotic systems.
