Orthopaedic surgical robotics developer THINK Surgical has received an additional 510(k) clearance from the US Food and Drug Administration (FDA) for its TMINI Miniature Robotic System.
The FDA approval allows the robotic, wireless handheld TMINI System to be used with the GMK Sphere and SpheriKA Knee Systems from Medacta International. The integration is a result of the collaboration agreement between THINK Surgical and Medacta announced concurrently.
The GMK Sphere and SpheriKA Knee Systems have been integrated into THINK Surgical’s ID-HUB, a proprietary database of implant modules designed for use with the open-platform version of the TMINI System.
The GMK Sphere implant is a ball-in-socket knee design, and the SpheriKA implant is said to be the world’s first knee system designed around Kinematic Alignment principles.
Adding both implants to the ID HUB database will allow Medacta US customers to access advanced robotic-assisted technology for total knee replacement.
THINK Surgical aims to offer orthopaedic surgical robots that accommodate implants from various manufacturers.
The TMINI Miniature Robotic System received FDA 510(k) clearance in May 2023.
THINK Surgical president and CEO Stuart Simpson said: “Medacta’s commitment to innovation aligns well with THINK Surgical’s dedication to innovation in robotics.
“We are excited to partner with Medacta in the USA to offer customers greater choice in patient treatment options.”
THINK Surgical’s TMINI System, when paired with GMK Sphere and GMK SpheriKA, enhances MyKA, a platform for Kinematic Alignment total knee replacement.
The combination also improves Medacta’s knee arthroplasty technologies, offering surgeons a robotic-assisted option for precise 3D CT-based planning.
In addition, it fits with the MySolutions Personalized Ecosystem, which includes the NextAR Augmented Reality Surgical Platform, MyKnee Patient Matched Technology, and Efficiency KneePack.
Medacta said that the partnership will help explore robotics in the US market and focus on the growing ambulatory surgery centre segment.
Medacta USA managing director and president Matt Goudy said: “I am pleased to announce our collaboration with THINK Surgical in the US Market.
“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 personalised solutions for surgeons and patients worldwide.”
Last month, the THINK Surgical received FDA clearance for the next-generation TMINI Miniature Robotic System (TMINI 1.1).
