THINK Surgical Gains FDA Clearance for Robotic Knee Replacement Application

By Julie A. Vetalice

THINK Surgical Gains FDA Clearance for Robotic Knee Replacement Application

THINK Surgical was granted FDA 510(k) clearance to market the TSolution One® Total Knee Application for total knee arthroplasty (TKA). TSolution One® includes an active robot for surgical planning. The CE Marked system has been available in Asia Pacific and European markets, where more than 550 TKA procedures have been completed to date.

The application employs TPLAN®, a 3D planning workstation, and TCAT® (shown below), a computer-assisted tool that executes the pre-surgical plan. TPLAN converts a CT scan of the patient’s joint into a three-dimensional surface model. The system has an open library of implants for use in the U.S. and EU. The surgeon chooses an implant, placing it along the a

xes of the bone with the help of anatomical landmarks. In the O.R., the TCAT computer-assisted tool uses the data from TPLAN to prepare the bone cavity and joint surface. Under control of the surgeon, TCAT mills the bone as specified by the plan.

"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. Bernard Stulberg, 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."

TSolution One received 510(k) clearance for a hip application in 2014.

Source: THINK Surgical, Inc.

Product Labels: Knee Replacement, Surgical Planning

Tags: ["510(k) Clearance","Regulatory"]