FDA Clears Think Surgical’s Robotic Surgical System

Fremont, Calif.-based Think Surgical Inc. has earned 510(k) clearance for its new Tsolution One surgical system for total hip arthroplasty (THA). The product is an active robotic system consisting of the Tplan 3-D planning workstation and the Tcat computer assisted tool.

The Tplan 3-D workstation assists surgeons with preoperative planning by creating a 3-D model of the patient’s anatomy based on CT (computed tomography) images. According to the company, the workstation tools allow the surgeon to study and select the surgical options, and plan an optimal fit and alignment for each patient.

In the operating room, the surgeon uses the Tcat computer-assisted tool and the patient’s preoperative plan to prepare the bone cavity and joint surface. Under the surgeon’s direct control, the Tcat system mills the bone with reported sub-millimeter accuracy to fit the implant the surgeon chose for the patient’s joint replacement.

Think Surgical makes robotic, computer-assisted surgical system for orthopedic surgery.