Think Surgical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its TMINI Miniature Robotic System (TMINI 1.1).
Designed for orthopaedic surgical robots, the system introduces substantial new capabilities, including the TMINI PRO workflow, which allows for positional refinement and optimisation tailored to patient needs during total knee arthroplasty procedures.
The workflow is engineered to empower surgeons with dynamic data capture and real-time feedback, enabling them to make positional adjustments to fine-tune implant positioning and stability.
Surgical plan adjustments are wirelessly transmitted to the TMINI Robot to streamline the surgical process.
The TMINI System features a wireless robotic handpiece that aids surgeons in performing total knee replacements.
It operates following a CT-based 3D surgical plan, which can be updated intraoperatively.
The robotic handpiece is designed to automatically compensate for hand movement, ensuring precise placement of bone pins and subsequent bone resection.
Think Surgical said that the TMINI is easy to use and can replace many traditional instruments used in manual knee replacement surgery.
Think Surgical president and CEO Stuart Simpson said: “This software release is a major enhancement to our TMINI Robotic System that not only meets our customers' needs but is a differentiator for our platform in this industry.
“It is a major accomplishment for our company to receive a second FDA clearance for our TMINI System in less than 15 months. This demonstrates our development capabilities and commitment to innovation as a focused robotics and digital surgery company.”
The company plans to expand its open implant library, providing additional options for its systems.
Last month, Think Surgical and medical technology company Zimmer Biomet signed a limited exclusive distribution and supply agreement.
As part of the agreement, Zimmer Biomet’s technology will be integrated into a customised TMINI robotic solution for total knee arthroplasty.
