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Home » FDA clears Think Surgical robot for use with Medacta knee systems

FDA clears Think Surgical robot for use with Medacta knee systems

August 30, 2024 By Sean Whooley

Think Surgical marketing image of its TMINI handheld ortho surgical robot.
The TMINI handheld ortho surgical robot [Image courtesy of Think Surgical]
Think Surgical announced that the FDA granted 510(k) clearance for its TMINI miniature robotic system for use with Medacta’s knee systems.

The FDA cleared TMINI for use with Medacta’s GMK Sphere and SpheriKA knee systems following a collaboration between the companies. Both knee systems have been added to the Think Surgical ID-HUB, a proprietary data bank of implant modules. They work with the open-platform version of the TMINI system.

Think Surgical said it aims to offer surgical robots that support implants from multiple manufacturers. Adding GMK Sphere, a leading ball-in-socket knee design, and SpheriKA, the world’s first knee system specifically designed on the principles of kinematic alignment, provides Medacta customers access to robotic assisted technology for total knee replacement in the U.S..

This latest clearance follows clearance for new software last month. The FDA first cleared the TMINI system for knee replacement procedures last year. The company has since added a number of implant options to its system. That includes collaborations with Maxx Orthopedics, b-ONE Ortho, Zimmer Biomet and Signature Orthopaedics.

“Medacta’s commitment to innovation aligns well with Think Surgical’s dedication to innovation in robotics,” said Stuart Simpson, president and CEO of Think Surgical. “We are excited to partner with Medacta in the U.S. to offer customers greater choice in patient treatment options.”

Filed Under: 510(k), Big Data, Food & Drug Administration (FDA), Health Technology, Implants, Orthopedic Implants, Orthopedics, Regulatory/Compliance, Robotic-Assisted, Software / IT, Surgical, Surgical Robotics Tagged With: FDA, Think Surgical

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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