FDA Clears Think Surgical’s 3D Workstation

THINK Surgical, Inc., formerly the Curexo Technology Corporation, has received 510(k) clearance from the U.S. Food and Drug Administration for its new TSolution One Surgical System for total hip arthroplasty (THA). The robotic system consists of two technologies. They are the Tplan 3D planning workstation and the TCAT computer-assisted tool. The two work together to bring about what the company calls “an exceptional degree of precision and accuracy” to total joint replacement surgery.

The TPLAN 3D workstation assists surgeons with preoperative planning by creating a 3D model of the patient’s anatomy based on CT images. Using the workstation tools the surgeon can plan an optimal fit and alignment for each patient.

According to the press release: “In the operating room, the surgeon uses the TCAT computer-assisted tool and the patient’s preoperative plan created by the surgeon to prepare the bone cavity and joint surface. Under the surgeon’s direct control, the TCAT system mills the bone with sub-millimeter accuracy to achieve optimal fit of the implant the surgeon chose for the patient’s joint replacement.”

According to company officials, “the Tsolution One core technologies have been used in thousands of total joint replacements for both hips and knees worldwide.” The company is based in Fremont, California.