Orthopedic robotic surgical platform developer Think Surgical said today it won expanded CE Mark approval in the European Union for its TSolution One surgical system, now cleared for use in total knee arthroplasty procedures.
The TSolution One system is designed to aid in creating personalized pre-surgical joint replacement plans using CT-based 3D planning and open implant library. The robotic platform then executes the surgical plan by removing diseased bone and preparing the bone cavity and joint surface, the Fremont, Calif.-based company said.
Think Surgical said the system has been shown to improve joint replacement implant fit and alignment compared to conventional joint replacement surgery, which it claims could reduce postoperative pain, complications and improve patient function.
“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. Obtaining the CE Mark represents a key milestone towards continuing the global commercialization of our differentiated robotic technology and our commitment to improving patients’ lives and partnering with surgeons to transform orthopedic surgery,” CEO John Hahn said in a press release.
The TSolution One surgical platform won its initial CE Mark in the European Union for total hip arthroplasty procedures in 2015, and has FDA 510(k) clearance for THA procedures in the US. The company said it is currently enrolling patients in an IDE study of the device as it seeks a TKA indication in the US.