Leading medical device company, THINK Surgical, Inc., has announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to sell the TSolution One® Total Knee Application for use in total knee arthroplasty (TKA) in the United States.
TSolution One® is a completely active robotic system which was previously awarded CE Marking and has been actively marketed in Asia Pacific and European markets. More than 550 TKA procedures have been successfully completed worldwide with the TSolution One® Total Knee Application to date.
“We are thrilled to expand the use of this state-of-the-art technology, which is truly transforming orthopedic surgery,” said John Hahn, CEO and president of THINK Surgical, Inc. “U.S. FDA clearance of TSolution One® furthers our commitment to improving the lives of patients suffering from severe osteoarthritis by expanding the global commercialization of our active robot for TKA. This significant achievement is a testament to our team’s dedication, and I am grateful for their hard work in making this vision a reality.”
The TSolution One® Total Knee Application includes CT-based 3D pre-surgical planning software which allows the surgeon to design and prepare, in a virtual environment, the patient’s unique knee joint replacement plan using a choice of knee implant options. During total knee replacement surgery, the surgeon implements the patient’s pre-planned procedure using the robot, which prepares the joint according to the surgeon’s plan for precise placement of knee implants.
Five surgeons participated in the clinical trial, which confirmed the safety and efficacy of the TSolution One® Total Knee Application compared to traditional knee replacement using manual surgical instrumentation. Study enrollment was completed in December 2018 and included 115 patients. The following surgeons participated in the study:
- Bernard Stulberg, M.D., (Cleveland, OH)
- Yair David Kissin, M.D., (Hackensack, NJ)
- Stefan Kreuzer, M.D., (Houston, TX)
- Ralph Liebelt, M.D., (Durham, NC)
- William Long, M.D., (New York, NY)
“What will be particularly appealing to surgeons is the open implant library offered by this active robotic system, which can achieve an optimal personalized surgical plan for each patient,” said Dr. Stulberg, an orthopedic surgeon and Principal Investigator in the U.S. clinical study of TSolution One®. “This innovative system will revolutionize the treatment of end-stage knee arthritis by coupling an individualized plan with precise bone cutting technology.”