TSolution One surgical system filed for 510(k) approval with FDA for knee replacement.

THINK Surgical has completed 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.

Comment: The TSolution One Surgical System first entered the European market in 2015 when it received CE Mark approval for Total Hip Arthroplasty (THA). Currently, the system has 510(k) clearance for THA in the United States and four centers are enrolling patients for an IDE clinical study for TKA. Earlier in the year, the TSolution One Surgical System received Korean-FDA clearance for both THA and TKA. It also received approval for sale in Israel by the Ministry of Health for THA.