Think Surgical Inc. announced it received CE mark approval for its TSolution One surgical system for total knee arthroplasty.
According to a company press release, the system received CE mark approval in 2015 for total hip arthroplasty and recently received Korean-FDA clearance for both TKA and THA. TSolution One also received approval for sale for THA in Israel by the Ministry of Health. It has 510(k) clearance for THA in the United States and four centers have enrolled patients for an IDE clinical trial of the system for TKA.
“We are pleased to offer one of the most advanced technologies in total knee replacement through the TSolution One Surgical System to the European market and other countries that rely on the CE mark,” John Hahn, CEO of Think Surgical, said in the release. “Obtaining the CE mark represents a key milestone toward continuing the global commercialization of our differentiated robotic technology and our commitment to improving patients’ lives and partnering with surgeons to transform orthopedic surgery.”
According to the release, the robotic system allows surgeons to customize the patient’s pre-surgical joint replacement plan with the use of CT-based 3-D planning and the system’s open implant library. The robot executes the patient’s surgical plan by removing diseased bone and prepares the bone cavity and joint surface.