Fact checked byMax R. Wursta

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November 11, 2023
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Surgical robot receives FDA special 510(k) clearance for use with additional implants

Fact checked byMax R. Wursta
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Key takeaways:

  • Think Surgical announced its TMINI miniature robotic system received FDA special 510(k) clearance for use with additional implants.
  • The system is intended to assist surgeons performing TKR.

Think Surgical Inc. announced its TMINI miniature robotic total knee replacement system has received special FDA 510(k) clearance for use with implants from three additional implant manufacturers, according to a press release.

The TMINI miniature robotic total knee replacement system has been cleared for use with the Klassic knee system (Total Joint Orthopedics Inc.), the Balanced knee system (BKS) and the BKS TriMax knee system (Ortho Development Corporation) and the U2 Knee (United Orthopedic Corporation).

Generic FDA News infographic
The TMINI miniature robotic total knee replacement system has received special FDA 510(k) clearance for use with additional implants. Image: Adobe Stock

“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,” Stuart Simpson, president and CEO of Think Surgical, said in the release. “We are currently working on adding more implant modules to the TMINI system to continue our mission of an open implant library,” Simpson added.