THINK Surgical Receives FDA 510(k) Clearance for Medacta GMK Sphere® and SpheriKA® implants on TMINI® Miniature Robotic System

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Aug 29, 2024, 13:00 ET

FREMONT, Calif., Aug. 29, 2024 /PRNewswire/ -- THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that its TMINI^®Miniature Robotic System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use with the GMK^® Sphere and SpheriKA^® Knee Systems from Medacta International under a Collaboration Agreement between the two companies.

The GMK Sphere and SpheriKA Knee Systems have been added to THINK Surgical's ID-HUB™, a proprietary data bank of implant modules for use with the open platform version of its TMINI System.

THINK Surgical is committed to providing orthopedic surgical robots that support implants from multiple manufacturers. The addition of the GMK Sphere implant, a leading ball-in-socket knee design, and the SpheriKA implant, the world's first knee system specifically designed based on the principles of Kinematic Alignment, to THINK Surgical's ID HUB database will allow Medacta customers access to robotic assisted technology for total knee replacement in the United States.

"I am pleased to announce our collaboration with THINK Surgical in the US Market," stated Matt Goudy, managing director and president of Medacta USA. "This partnership marks another step forward in our commitment to offering cutting-edge technologies that drive sustainable innovation forward and enhance our ability to deliver personalized solutions for surgeons and patients worldwide."

"Medacta's commitment to innovation aligns well with THINK Surgical's dedication to innovation in robotics." said Stuart Simpson, president, and chief executive officer of THINK Surgical. "We are excited to partner with Medacta in the USA to offer customers greater choice in patient treatment options."

About THINK Surgical, Inc.

THINK Surgical, Inc., is a privately held U.S.-based technology innovator that develops and markets orthopedic robots.

THINK Surgical actively collaborates with healthcare professionals to refine our orthopedic products, improving the lives of those suffering from advanced joint disease with precise, accurate, and intelligent technology.  Please refer to the instructions for use for the TMINI Miniature Robotic System for a complete list of indications, contraindications, warnings, and precautions. For additional product information, please visit www.thinksurgical.com. 

THINK Surgical and TMINI are trademarks of THINK Surgical, Inc.

About Medacta

Medacta is an international company specializing in the design, production, and distribution of innovative orthopaedic products, as well as in the development of accompanying surgical techniques. Established in 1999 in Switzerland, Medacta is active in joint replacement, spine surgery, and sports medicine. Medacta is committed to improving the care and well-being of patients and maintains a strong focus on healthcare sustainability. Medacta's innovation, forged by close collaboration with surgeon experts globally, began with minimally invasive surgical techniques and has evolved into personalized solutions for every patient. Through the M.O.R.E. Institute, Medacta supports surgeons with a comprehensive and tailored program dedicated to the advancement of medical education. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 50 countries. For additional product information, please visit www.medacta.us.com

GMK Sphere and SpheriKA are trademarks of Medacta International, SA

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