THINK Surgical has received CE Mark approval for the TSolution One surgical system, bringing active robotic precision to Total Knee Arthroplasty (TKA).
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.
"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," said John Hahn, CEO of THINK Surgical, Inc.
"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."
TSolution One is a robotic system that enables surgeons to create the patient's personalized pre-surgical joint replacement plan, using CT-based 3D planning and the system's open implant library to achieve an optimized surgical plan.
During surgery, the robot precisely executes the patient's individual surgical plan by removing diseased bone and preparing the bone cavity and joint surface with sub-millimeter dimensional accuracy.1
THINK's active robotic technology has been shown to improve joint replacement implant fit and alignment as compared to conventional joint replacement surgery.2 Accurate implant fit and alignment may be responsible for reduced postoperative pain, complications, and improved patient function.3,4