FDA clears Zimmer Biomet Persona Knee System with Think Surgical robot

By Sean Whooley | September 9, 2024

THINK Surgical Inc. last week announced that the U.S. Food and Drug Administration has granted 510(k) clearance for the use of its TMINI surgical robot with Zimmer Biomet Robotics’ Persona 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 outpatient setting,” stated Stuart Simpson, CEO of Think Surgical.

Fremont, Calif.-based THINK Surgical develops and markets orthopedic robots. The privately held company claimed that its robots are open platforms that support implant brands from multiple manufacturers. This allows surgeons to drive the choice of implant, it said.

Register now.

THINK Surgical continues surgical robot partnerships

THINK Surgical called the availability of Persona on an exclusive version of TMINI “a major milestone.” The company entered into a limited distribution agreement with Zimmer Biomet earlier this year.

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 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.

This latest clearance follows FDA clearance for TMINI with Medacta knee systems last week, plus clearance for new software in July.

THINK Surgical claimed that the FDA approval makes it “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.”

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.

Zimmer Biomet offers Persona, TMINI for knee replacement

Dr. Nitin Goyal, Zimmer Biomet’s chief science, technology, and innovation officer, said his company‘s deal with THINK Surgical made it the first to offer two complementary systems for robot-assisted knee-replacement surgery. The partners said they plan to introduce the customized TMINI system in select U.S. markets in the second half of 2024.

Think Surgical said 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 Persona knee system, it said.

Zimmer Biomet, which has offices in Montpelier, France, and Warsaw, Ind., also offers the flagship Rosa platform. Rosa, which recently expanded into shoulder replacement, has four applications, including the knee.

Editor’s note: This article was syndicated from The Robot Report sibling site MassDevice.