THINK Surgical Receives FDA 510(k) Clearance for TMINI Miniature Robotic System

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May 30, 2023, 10:00 ET

FREMONT, Calif., May 30, 2023 /PRNewswire/ -- THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that its TMINI™ Miniature Robotic System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

The TMINI system includes a wireless robotic handpiece that assists surgeons in performing total knee replacement. Following a CT based three-dimensional surgical plan, 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 is easy to use and replaces many of the instruments currently used for knee replacement surgery.

THINK Surgical is committed to an open implant library and will continue to add new implant options to the platform over time. This open implant approach combined with the ease of use of the TMINI system should appeal to a broad customer base who may have been resistant to robotics until now.

THINK Surgical designed the TMINI robotic handpiece in collaboration with Sagentia Innovation, an R&D consultancy based in Cambridge, U.K. The combined technical expertise of both companies enabled the innovative design of the TMINI robotic handpiece which is easily integrated into operating room workflows by surgeons and staff.

"With its small footprint, open implant platform and intuitive workflow, the TMINI system opens up robotic possibilities for more clinics, operating rooms, and surgeons," said Stuart Simpson, president, and chief executive officer of THINK Surgical.

"The broader market opportunity for the TMINI system makes this an important development in surgical robotics. It's been exciting supporting this project from early concept development through transfer-to-manufacture, and we look forward to its commercial success," said Duncan Smith, managing partner of Sagentia Innovation.

About THINK Surgical, Inc.

THINK Surgical, Inc., is a privately held U.S.-based technology innovator that develops and markets orthopedic robots. THINK Surgical robots are open platforms providing support for implant brands from multiple manufacturers, enabling the choice of implant to be driven by the surgeon.

THINK Surgical actively collaborates with healthcare professionals around the globe to refine our orthopedic products, improving the lives of those suffering from advanced joint disease with precise, accurate, and intelligent technology. Please refer to the instructions for use for the TMINI Miniature Robotic System for a complete list of indications, contraindications, warnings, and precautions. For additional product information, please visit www.thinksurgical.com.

THINK Surgical and TMINI are trademarks of THINK Surgical, Inc.

About Sagentia Innovation

Sagentia Innovation is a science and engineering R&D consultancy based in Cambridge, U.K. that offers product advisory and development services driven by insight and invention.

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