Think Surgical Secures FDA Approval for Its Knee Replacement Robot

Think Surgical, a manufacturer of orthopedic robotics, has secured its third FDA approval in the last three months. This latest approval is for a highly customized variant of its knee replacement system, specifically designed to be used with an implant manufactured by Zimmer Biomet.

In May 2023, the TMINI platform received its first FDA clearance. The platform features a wireless, portable instrument that relies on a three-dimensional model generated from a CT scan to assist surgeons in the accurate placement of bone pins and cutting guides.

In July, Think Surgical obtained an updated 510(k) clearance for variant 1.1 of the system. According to the company, this version includes the ability to adjust the location of the replacement joint and balance the soft tissue.

While developing its robotic method, the company has worked on two distinct approaches: one with an open framework capable of being used with a variety of hardware, and another designed for exclusive use with a specific implant model or manufacturer.

Both approaches received FDA approvals in August and September. Think Surgical collaborated with Medacta International to provide compatibility for their GMK Sphere and SpheriKA knee systems within the open platform.

Shortly after, the company announced that its unique, modified system would be compatible with Zimmer Biomet’s Persona knee.

“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 outpatient settings,” said Think Surgical CEO Stuart Simpson.

Think Surgical and Zimmer Biomet had previously signed a limited distribution agreement for the proprietary version of TMINI, unveiled in June this year.

Simpson noted that the company recognizes two distinct customer groups: one that prefers an open platform allowing them to choose from various implants to use with the robot, and another that favors an exclusive system, which grants access to the robot in exchange for brand loyalty to a single implant manufacturer. He added that these two customer segments are roughly equal in size.

Simpson believes this flexibility is what sets the company apart from its competitors. The ability for surgeons to choose from multiple manufacturers allows them to derive more significant benefits from robotic-assisted surgery, while also simplifying the process of selecting the ideal implant for each patient.

In terms of partnerships, the company anticipates that its device will be able to support around 40% of the total knee implants currently available on the market.