THINK Surgical Submits to the U.S. FDA for Clearance to Market its Active Robot for use in Total Knee Replacement Procedures

Friday, May 24, 2019 General News
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FREMONT, Calif., May 23, 2019 /PRNewswire/ -- THINK Surgical, Inc. ("THINK") announces completion of enrollment for the U.S. investigational clinical study and submission of the 510(k) to obtain clearance from FDA to market its active robot, TSolution OneŽ, for use in total knee replacement procedures. 

TSolution OneŽ Total Knee Application uses a CT-based 3D pre-surgical

planning program for the surgeon to design and prepare, in a virtual environment, the patient's unique knee joint replacement plan using a selection of knee implant options. During total knee replacement surgery, the surgeon implements the patient's pre-planned surgery using the robot that prepares the joint, according to the surgeon's plan, for placement of the knee implants. 

"The completion of the U.S. clinical study enrollment and submission of the 510(k) using the modern robot surgical system, TSolution OneŽ, is a major milestone in preparing to bring transformational robotic technology to orthopedics in the U.S.," commented John Hahn, CEO and President of THINK.

THINK has received the CE Mark and has been actively marketing its TSolution OneŽ in Asia Pacific and European markets.  

About THINK Surgical, Inc. THINK Surgical, Inc. is committed to the future of orthopedic surgery and to improving patient care through the development of leading-edge precision technology. THINK Surgical develops, manufactures and markets active robotics for orthopedic surgery and maintains an open implant policy, allowing surgeons maximum choice for their patients. For more information, visit www.THINKSurgical.com.

Contact

Cynthia KalbTHINK Surgical, Inc.ckalb@thinksurgical.com

Cision View original content:http://www.prnewswire.com/news-releases/think-surgical-submits-to-the-us-fda-for-clearance-to-market-its-active-robot-for-use-in-total-knee-replacement-procedures-300856395.html

SOURCE THINK Surgical, Inc.



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