December 16, 2020
THINK Surgical advises their new system will be available to hospitals and ambulatory surgery centers in the United States in early 2021 following recent clearance by the Food and Drug Administration (FDA).
THINK Surgical is also preparing to upgrade systems currently in use throughout the United States. THINK’s TSolution One® Total Knee Application performs fully automated preparation of the bone and joint surface and supports an open platform enabling a choice of implants by surgeons.
“The new system has even more flexibility in preoperative planning and improved intraoperative efficiency in the set-up time,” said Stefan Kreuzer, M.D., founder of INOV8 Orthopedics in Houston, Texas, who has participated in validation labs, including clinical evaluation, of the second-generation system. INOV8 Surgical was the first ambulatory surgery center in the United States to receive the first-generation TSolution One Total Knee Application earlier this year. “As with the initial TSolution One Total Knee Application, the enhanced system provides submillimeter dimensional accuracy cuts optimizing the marriage of the implant to the bone. I am looking forward to utilizing the new system to further improve patient care.”
The second-generation system incorporates several enhancements to the hardware and software including streamlined preoperative diagnostics; the addition of audio feedback to improve positional guidance during surgery; recovery marker detection to alert the surgeon if recovery markers are within the cut path; upgraded registration and cutting visualization; registration enhancements to reduce the time for bone registration; and a redesigned cutter drive assembly.
In addition, the new robot features LED lights to indicate various stages in the procedure.
“The new system will streamline the registration process to increase efficiency in the operating room, getting patients through the procedure faster,” said Yair D. Kissin, M.D., vice chair, Orthopedic Surgery at Hackensack University Medical Center, which was the first hospital in the country to use the FDA cleared TSolution One Total Knee Application earlier this year. “I am excited to use the new system to advance our total joint replacement surgery program.”
THINK Surgical received FDA 510(k) clearance of the second-generation active robot on November 13, 2020, approximately one year after the first-generation system was cleared. As the new year approaches, THINK looks forward to engaging with new customers and demonstrating its unique and innovative technology for total knee replacement procedures.
“Receiving FDA clearance on our second-generation system demonstrates our team’s dedication to the continuous improvement of our active robot technology,” said Jay Yang, acting CEO, THINK Surgical. “The TSolution One Total Knee Application aims to improve patient satisfaction and expand the reproducibility of favorable outcomes in hospitals and ambulatory surgery centers. We are excited to introduce our technology to more orthopedic surgeons, helping them to improve the lives of patients who suffer from severe osteoarthritis.”
The TSolution One Total Knee Application system is comprised of TPLAN®, the 3D pre-surgical planning workstation, and TCAT®, the active robot that helps the surgeon execute each patient’s individual preoperative plan with consistent results.