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Think Surgical’s TMINI Surgical Robot Wins FDA Nod for b-ONE Ortho’s MOBIO Knee

This marks Think Surgical's third announcement for such an FDA clearance this week, adding five knees to its ID-HUB.

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By: Sam Brusco

Associate Editor

Think Surgical announced that its TMINI miniature robotic system has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for use with b-ONE Ortho’s MOBIO total knee system, under a collab agreement between the duo.

The MOBIO total knee was added to Think Surgical’s ID-HUB, a databank of implant modules for use with the open platform version of TMINI in the U.S. Yesterday, the company revealed an FDA nod for TMINI to be used with three knee systems from Maxx Orthopedics.

On Monday, the company also announced that TMINI had been FDA cleared for use with the LinkSymphoKnee from Waldemar Link. In September, TMINI earned an FDA OK for an implant-exclusive option with Zimmer Biomet’s Persona knee, making it the only company at present with both an implant-exclusive option with the Persona knee and an open platform for implants from multiple other manufacturers for total knee replacement.

“Think Surgical is excited to add the MOBIO Total Knee System to the TMINI System,” said Think Surgical president and CEO Stuart Simpson. “The open platform version of TMINI is now available with eight different knee designs from eight separate orthopedic companies offering surgeons the choice of single-radius, anatomic, and guided motion knees on a single robotic platform.”

In July 2024, the company also received FDA clearance for new TMINI system software with new features to help surgeon choice in total knee replacement.

“We are very enthusiastic about receiving this clearance for use with the Think Surgical TMINI System platform, which not only enhances our MOBIO Total Knee System portfolio in offering our customers a robotic assisted technology solution, but it also provides b-ONE greater market penetrating strategic options and solutions,” said b-ONE Ortho general manager Jim Duncan. “We look forward to this continued partnership with Think Surgical offering a proven total knee design that can provide a smooth transition for many surgeons across the United States.”

Learn more about Think Surgical and other “hot prospect” orthopedic device companies here!

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