Orthopaedic surgery company THINK Surgical Inc said on Thursday that has filed for the US FDA's 510(k) market clearance for its active robot, TSolution One, for use in total knee replacement procedures.
The company also revealed that it has completed enrolment for the US investigational clinical study of TSolution One.
The 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.
THINK has previously received the CE Mark and has been actively marketing its TSolution One in Asia Pacific and European markets.
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