The FDA cleared Think Surgical's TSolution One Total Knee Application for use in total knee arthroplasty in the U.S.
What you should know:
1. The robot was already in use in the Asia Pacific and Europe markets, with more than 550 TKA procedures performed to date.
2. The robot includes 3D presurgical planning software to design and visualize the entire procedure beforehand. During a procedure a surgeon can use the robot to prepare the patient's joint according to the designed presurgical plan. This preparation ensures a knee implant is placed as precisely as possible.
4. The FDA based its approval on a U.S.-based clinical trial that included 115 patients.