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Home » FDA clears Think Surgical’s TMINI 1.1 miniature surgical robot software

FDA clears Think Surgical’s TMINI 1.1 miniature surgical robot software

July 23, 2024 By Sean Whooley

Think Surgical TMINI miniature robotic system
[Image courtesy of Think Surgical]
Think Surgical announced today that the FDA granted 510(k) clearance for its TMINI miniature robotic system (TMINI 1.1).

TMINI 1.1 software provides new capabilities to empower surgeon choice throughout total knee arthroplasty (TKA) procedures. Its new TMINI Pro workflow enables positional refinement and optimization of the implant tailored to patient needs. The workflow’s dynamic data capture and real-time feedback enables surgeons to make positional adjustments. This helps fine-tune implant positioning and stability.

Fremont, California-based Think Surgical designed the workflow for customization around surgeon preferences and implant philosophy choices. Users can wirelessly transmit surgical plan adjustments to the TMINI robot for a seamless experience.

TMINI features a wireless robotic handpiece that assists surgeons in performing total knee replacement. After a CT-based 3D surgical plan, the handpiece automatically compensates for surgeon hand movement, locating bone pins along precisely defined planes. It then connects cutting guides to the bone pins for accurate bone resection.

Clearance for the software comes just over a year after the FDA first cleared the TMINI system for knee replacement procedures. The company has since added a number of implant options to its system. That includes collaborations with Maxx Orthopedics, b-ONE Ortho, Zimmer Biomet and Signature Orthopaedics.

“This software release is a major enhancement to our TMINI robotic system that not only meets our customers’ needs but is a differentiator for our platform in this industry,” said Stuart Simpson, president, and CEO of Think Surgical. “It is a major accomplishment for our company to receive a 2nd FDA clearance for our TMINI system in less than 15-months.  This demonstrates our development capabilities and commitment to innovation as a focused robotics and digital surgery company.”

Filed Under: 510(k), Food & Drug Administration (FDA), Orthopedic Implants, Orthopedics, Regulatory/Compliance, Robotic-Assisted, Surgical, Surgical Robotics Tagged With: FDA, Think Surgical

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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