Think Surgical has gained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its TMINI miniature robotic system (TMINI 1.1)

TMINI 1.1’s new system software has new features to help surgeon choice in total knee arthroplasty (TKA) procedures. The new TMINI PRO allows positional refinement and optimization of the implant tailored to patient needs. Dynamic data capture and real-time feedback allow positional adjustments to be made to fine-tune implant positioning and stability.

The company said TMINI PRO is intuitive and customizable to surgeon preferences and implant philosophy choices. Adjustments to the surgical plan are transmitted wirelessly to the TMINI robot.

“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, Think Surgical’s president and CEO. “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.”  

More about the TMINI system

The TMINI system includes a wireless robotic handpiece that helps surgeons perform total knee replacement. 

After a CT-based, 3D surgical plan which may be updated following intra-op joint assessment, the TMINI robotic handpiece automatically compensates for surgeon hand movement to locate bone pins along precisely defined planes. Cutting guides are then connected to the bone pins for accurate bone resection. TMINI replaces many of the instruments currently used for manual knee replacement surgery. 

Think Surgical plans to continue adding new implant options to its open implant library. The company believes that the choice of exclusive platform or open implant platform, combined with the robust feature offering and ease of use of the TMINI system, will appeal to a broad customer base who may be resistant to robotics.

Last month, the company began a limited distribution agreement for TMINI with orthopedic giant Zimmer Biomet.