THINK Surgical, Inc. (“THINK”) announces completion of enrollment for the U.S. investigational clinical study and submission of the 510(k) to obtain clearance from FDA to market its active robot, TSolution One®, for use in total knee replacement procedures.
TSolution One® Total Knee Application uses a CT-based 3D pre-surgical planning program for the surgeon to design and prepare, in a virtual environment, the patient’s unique knee joint replacement plan using a selection of knee implant options. During total knee replacement surgery, the surgeon implements the patient’s pre-planned surgery using the robot that prepares the joint, according to the surgeon’s plan, for placement of the knee implants.
“The completion of the U.S. clinical study enrollment and submission of the 510(k) using the modern robot surgical system, TSolution One®, is a major milestone in preparing to bring transformational robotic technology to orthopedics in the U.S.,” commented John Hahn, CEO and President of THINK.
THINK has received the CE Mark and has been actively marketing its TSolution One® in Asia Pacific and European markets.