FDA Special 510(k) Clearance for Use With Additional Implants
(FREMONT, CA) Oct 23, 2023 – THINK Surgical, Inc., an innovator in the field of 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 assists surgeons in performing total knee replacement and first received 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 Klassic® 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 data bank of implant modules for use with the TMINI System, opens up access and choice for surgeons.
“We are excited to expand the number of implant modules supported by the TMINI system, allowing more customers and patients access to robotic assisted technology for knee replacement.” said Stuart Simpson, president, and chief executive officer 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 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.