The FDA awarded Think Surgical FDA 510(k) clearance for its TSolution One Total Knee Application, which incorporates 3D presurgical planning software into a knee replacement procedure.
With the application, surgeons can design and prepare for a patient's knee replacement in a virtual environment that carries over into the actual procedure with a surgical robot which implements the planned procedure.
Five surgeons tested the application on a total of 115 patients. Think was assisted by MCRA, which oversaw the clinical trial.