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THINK Surgical’s TMINI System Receives Special 510(k) Clearance from the FDA for Use with Complementary Implants

FREMONT, Calif., Oct. 23, 2023 /PRNewswire/ — THINK Surgical, Inc., an innovator in orthopedic surgical robots, today announced that its TMINI™ Miniature Robotic System has received special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use with implants from three additional implant manufacturers.

The TMINI system includes a wireless robotic handpiece that helps surgeons perform total knee replacements and received its first 510(k) clearance from the U.S. FDA in April 2023 for use with an implant from a single implant manufacturer.

THINK Surgical is committed to an open implant library. The addition of the Classic® Knee System (Total Joint Orthopedics Inc.), Balanced Knee System (BKS®) and BKS TriMax® Knee System (Ortho Development Corporation) and U2™ Knee (United Orthopedic Corporation) to THINK Surgical’s Implant Data Hub (ID-HUB), a proprietary database of implant modules for use with the TMINI System, opens access and choice to surgeons.

“We are excited to expand the number of implant modules supported by the TMINI system, giving more customers and patients access to robot-assisted technology for knee replacement.” said Stuart Simpson, president and CEO of THINK Surgical. “We are currently working on adding more implant modules to the TMINI system to continue our mission of an open implant library.”

About THINK Surgical, Inc.

THINK Surgical, Inc. is a privately held, US-based technology innovator that develops and commercializes orthopedic robots. THINK Surgical robots are open platforms that support implant brands from multiple manufacturers, allowing the surgeon to determine the implant choice.

THINK Surgical actively works with healthcare professionals around the world to refine our orthopedic products to improve the lives of people suffering from advanced joint conditions with accurate, precise and intelligent technology. Refer to the TMINI Miniature Robotic System Instructions for Use 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.

Media contacts:

THINK surgical
Nick Margree
nmargree@thinksurgical.com

SOURCE THINK Surgical, Inc.

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