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American medical technology company THINK Surgical announced that its TMINI Miniature Robotic System (TMINI 1.1) has obtained 510(k) clearance from the US Food and Drug Administration (FDA).
The TMINI 1.1 system software introduces new advancements that enhance surgeon decisions during total knee arthroplasty procedures.
The system now includes the TMINI PRO workflow that facilitates the positional refinement and optimisation of implants personalised to each patient.
According to THINK Surgical, the dynamic data capture of the workflow and real-time feedback enable surgeons to adjust positions and fine-tune the implant’s placement and stability.
In addition, the intuitive TMINI PRO workflow is customisable to accommodate surgeon preferences and implant philosophies, as per the orthopaedic surgical robot developer.
Surgical plan modifications are transmitted wirelessly to the TMINI Robot, ensuring a streamlined surgical process.
The TMINI System features a wireless robotic handpiece designed to aid surgeons in total knee replacement procedures.
It operates based on a CT-derived three-dimensional surgical plan, which can be updated following intraoperative joint assessment.
The robotic handpiece adjusts automatically to make up for surgeon’s hand movements, accurately positioning bone pins along defined planes. Subsequently, cutting guides are attached to these bone pins for precise bone resection.
THINK Surgical said that TMINI simplifies the surgical process and replaces several traditional instruments used in manual knee replacement surgeries.
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 2nd 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.”
THINK Surgical aims to expand customer access to its handheld TMINI Miniature Robotic System.
In the future, the surgical robots developer plans to expand its open implant library by incorporating additional implant options.
Last month, the company signed a distribution and supply agreement with Zimmer Biomet to integrate ZB technology into a customised TMINI robotic solution for total knee arthroplasty.