The orthopedic robotics developer Think Surgical has collected its third FDA clearance in as many months, with a specialized version of its knee replacement system designed to be paired with an implant from Zimmer Biomet.
The company’s TMINI platform first received an agency green light in May 2023, featuring a wireless, handheld tool that relies on a three-dimensional model built from a CT scan to help guide surgeons in the accurate placement of bone pins and cutting guides.
Think Surgical obtained an updated 510(k) for version 1.1 of the system in July, which it said added the ability to refine the position and soft-tissue balance of the replacement joint.
The company has been developing its robotic approach on two different tracks: one with an open platform capable of being used with a range of hardware, and one that can be used exclusively with a single implant brand or manufacturer.
August and September have brought FDA clearances on both sides of that coin. For the open platform, Think Surgical collaborated with Medacta International to add support for its GMK Sphere and SpheriKA knee systems.
Shortly afterward, the company announced last week that its exclusive, customized system will work with Zimmer Biomet’s Persona knee.
“TMINI addresses surgeon demand for ergonomic, wireless, handheld robotic systems and we believe this will accelerate adoption of robotics in knee procedures, particularly in the out-patient setting,” Think Surgical CEO Stuart Simpson said in a statement.
Think Surgical and Zimmer Biomet previously inked a limited distribution deal, tied to the exclusive version of TMINI, which was announced this past June.
“We believe that there are two distinct customer segments, one which prefers an open platform where the customer can choose from a range of implants on the robot and another which prefers an exclusive platform where the customer gains access to the robot in return for loyalty to a single implant brand,” Simpson said at the time. “We believe that these two customer segments are approximately equal.”
The company estimates that, among its collaborations, its device can support about 40% of the total knee implants on the market.