THINK Surgical Receives FDA 510(k) Clearance for MOBIO™ Knee System implants on TMINI® Miniature Robotic System

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Nov 20, 2024, 10:00 ET

FREMONT, Calif., Nov. 20, 2024 /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) for use with the MOBIO^™ Total Knee System from b-ONE Ortho Corporation (Cedar Knolls, NJ) under a Collaboration Agreement between the two companies.

The MOBIO^™ Total Knee System has been added to THINK Surgical's ID-HUB™, a proprietary data bank of implant modules for use with the open platform version of its TMINI System in the United States.

"THINK Surgical is excited to add the MOBIO^™ Total Knee System to the TMINI System. 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." said Stuart Simpson, president, and chief executive officer of THINK Surgical.

"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. 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", said Jim Duncan, General Manager of b-ONE Ortho Corporation.

About THINK Surgical, Inc.

THINK Surgical, Inc., is a privately held U.S.-based technology innovator that develops and markets orthopedic robots.

THINK Surgical actively collaborates with healthcare professionals 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 b-ONE Ortho Corporation

b-ONE Ortho is a Global Manufacturer based out of Cedar Knolls, New Jersey. We, at b-ONE, are committed to improving the experience of both patients and surgeons through innovative technologies. With our passion for advanced manufacturing, advanced material science, artificial intelligence, and robotics, we relentlessly pursue ways to offer best in class healthcare solutions while increasing healthcare economic value. Our goal is to help more patients worldwide to gain their active lifestyle back with the best means humankind ever created-innovative technology.

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