FDA Clears THINK Surgical’s TMINI System FDA for Use With Additional Implants

THINK Surgical has received FDA special 510(k) clearance for its TMINI™ Miniature Robotic System for use with implants from three additional implant manufacturers, including Total Joint Orthopaedics’ Klassic® Knee System, Ortho Development’s Balanced Knee System (BKS®) and BKS TriMax® Knee System, and United Orthopedic’s U2™ Knee.

These additions to THINK Surgical’s Implant Data Hub (ID-HUB), a proprietary data bank of implant modules for use with the TMINI System, will open up access and choice for surgeons.

The TMINI System, which includes a wireless robotic handpiece that assists surgeons in performing total knee arthroplasty, first received 510(k) clearance from the US FDA in April 2023 for use with an implant from a single implant manufacturer.

The expanded implant modules supported by the TMINI System will allow more customers and patients access to robotic-assisted technology for knee replacement, and THINK Surgical is working to add additional implant modules to the TMINI System with the mission of an open implant library,” said Stuart Simpson, President and CEO of THINK Surgical.

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