THINK Surgical completed enrollment for a U.S. investigational clinical study to support an FDA 510(k) to market the TSolution One® active robot for use in total knee replacement.
TSolution One supports the creation of a patient-specific pre-surgical joint replacement plan using CT-based 3D planning and an open implant database. The robot helps to remove diseased bone and prepare the joint surface.
The system received FDA 510(k) clearance for use in total hip replacement in 2014, followed by CE Mark approval for the same application in 2015. In other geographies, the system has Korean FDA clearance for total hips and knees, and is approved for total hips in Israel.
Julie A. Vetalice is ORTHOWORLD’s Editorial Assistant.