Think Surgical announced today that it received FDA 510(k) clearance for the use of its TMINI surgical robot with the Zimmer Biomet (NYSE: ZBH) + Persona system.

The FDA cleared the miniature surgical robot for use with the orthopedic giant’s Personalized Knee System. Clearance makes Think Surgical the only company offering a robotic system providing both an implant-exclusive option with the Persona Knee system and an open implant platform for use with implants from multiple other manufacturers for total knee arthroplasty.

In a news release, the Fremont, California-based company called the availability of Persona on an exclusive version of TMINI “a major milestone.” The company already entered into a limited distribution agreement with Zimmer Biomet earlier this year.

Dr. Nitin Goyal, Zimmer Biomet’s chief science, technology and innovation officer, said at the time that the deal made the company the first to offer two complementary robotic systems for surgeons looking to incorporate robotic assistance while performing a knee replacement. They expected at that point to introduce the customized TMINI system in select U.S. markets in the second half of 2024. (Zimmer Biomet also offers the flagship Rosa platform. Rosa, which recently expanded into shoulder replacement, has four applications, including the knee.)

Think Surgical says its go-to-market strategy supports two distinct customer segments. One segment prefers an open platform where customers can choose from a range of implants on the robot. The other prefers an exclusive platform with the market-leading Persona Knee system.

“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,” said Think Surgical CEO, Stuart Simpson.

More about the Think Surgical TMINI system working with the Zimmer Biomet Persona Knee

TMINI, which received FDA clearance in May 2023, features a wireless, robotic handpiece. It assists surgeons in performing total knee replacement.

Following a CT-based three-dimensional surgical plan, the TMINI robotic handpiece automatically compensates for the surgeon’s hand movement to locate bone pins along precisely defined planes. Cutting guides are then connected to the bone pins for accurate bone resection.

Think Surgical says it aims to offer surgical robots that support implants from multiple manufacturers. This latest clearance follows FDA clearance for TMINI with Medacta knee systems last week, plus clearance for new software in July.  The company has since added a number of implant options to its system. That includes collaborations with Maxx Orthopedics, b-ONE Ortho and Signature Orthopaedics.