THINK Surgical, Inc. announced that Houston-based INOV8 Surgical is the first health care facility in the state of Texas to acquire the TSolution One® active robot system, since the technology was cleared by the U.S. Food and Drug Administration (FDA) for use in the United States.

“We are proud to collaborate with Dr. Stefan Kreuzer and his team at INOV8 Surgical to offer patients the TSolution One Total Knee Application,” said John Hahn, CEO of THINK Surgical, Inc. “Our active robot technology is advancing the field of orthopedic surgery by helping surgeons perform total knee replacement procedures with more accuracy and precision. The system also offers an open implant library, which allows surgeons to select the implant that is best suited for their patient from an array of options.”

“We are very excited to be the first center in Texas to offer our patients this innovative technology since it received clearance from the FDA,” said Stefan Kreuzer, M.D., founder, INOV8 Orthopedics.

The TSolution One Total Knee Application combines two exclusive innovations in total joint replacement surgery. The system consists of TPLAN®, a 3D pre-surgical planning workstation and TCAT®, the active robot. The pre-surgical planning allows the surgeon to design and prepare, in a virtual environment, the patient’s unique joint replacement plan using a choice of implant options. Total joint replacement surgery involves removing the diseased knee joint and replacing it with a joint implant. During the joint replacement surgery, the surgeon implements the patient’s pre-planned procedure using the active robot, which prepares the joint according to the surgeon’s plan for precise placement of implants.

October 9, 2019, Fremont, California-based THINK Surgical, Inc. announced it received clearance from FDA to market the TSolution One Total Knee Application for use in Total Knee Arthroplasty (TKA) in the United States. Five surgeons, including Dr. Kreuzer in Houston, TX, participated in the investigational clinical trial, which confirmed the safety and efficacy of the TSolution One Total Knee Application compared to traditional knee replacement using manual surgical instrumentation.  The other sites included Cleveland, OH; Hackensack, NJ; Durham, NC; and New York, NY. Study enrollment was completed in December 2018 and included 115 patients.

TSolution One 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.

Source: Company Press Release