THINK Surgical has received the US Food and Drug Administration (FDA) 510(k) approval for its TMINI Miniature Robotic System for use with the Persona The Personalized Knee System from Zimmer Biomet.
Based in California, THINK Surgical is a medical technology company that develops, manufactures, and markets active robotic surgical systems for orthopaedic surgery.
The company designed its TMINI System with a small footprint, open implant platform and intuitive workflow, for accurate implant placement and advanced uptake of orthopaedic robotics.
Zimmer Biomet is a publicly traded medical device company based in Warsaw, Indiana, providing implants and digital technologies.
Its Persona The Personalized Knee System features personalised implants, precise instrumentation, and advanced technology.
In June this year, Zimmer Biomet and THINK Surgical signed a limited distribution agreement, to integrate Zimmer Biomet’s technology into TMINI Miniature Robotic System.
THINK Surgical said the integrated robotic system provides both an implant-exclusive option and an open implant platform for use with implants from other manufacturers.
Its go-to-market strategy supports two distinct segments of customers, one who prefers an open platform, which allows the customers to choose from a range of implants on the robot.
The integrated robotic system also caters to the other segment of customers who prefer an exclusive platform with the Persona Knee System, said the surgical robotics company.
THINK Surgical CEO Stuart Simpson said: “TMINI addresses surgeon demand for ergonomic, wireless, handheld robotic systems and we believe this will accelerate the adoption of robotics in knee procedures, particularly in the out-patient setting.”
In July this year, THINK Surgical received the FDA 510(k) approval for its TMINI Miniature Robotic System (TMINI 1.1) with updated software for enhanced surgeon decisions.
Last month, the US health agency granted an expanded 510(k) approval for TMINI System, for use with GMK Sphere and SpheriKA Knee Systems from Medacta International.
