Think Surgical Tmini Robot and Software Cleared

FDA has cleared a Think Surgical 510(k) for its Tmini Miniature Robotic System with Tmini 1.1. software for total knee arthroplasty procedures. The device’s Tmini PRO workflow “enables positional refinement and optimization” of the implant tailored to a patient’s needs, the company says. “The workflow’s dynamic data capture and real-time feedback allows surgeons to make positional adjustments to help fine-tune implant positioning and stability.” The company says surgical plan adjustments are also wirelessly transmitted to the robot.

The device is designed to follow a computed tomography-based, three-dimensional surgical plan which may be updated following intraoperative joint assessment, the company says. The handpiece also “compensates for surgeon hand movement to locate bone pins along precisely defined planes,” it says, adding that cutting guides are then connected to the bone pins for accurate bone resection.