US-based medical device company THINK Surgical has received 510(k) clearance from the US Food and Drug Administration (FDA) for its TMINI robotic system.
The small, handheld, and wireless TMINI solution is a surgical implant tool for knee replacement surgery.
With the ability to compensate for the surgeon’s hand movement, the medical device locates bone pins using a CT-based three-dimensional surgical plan. Cutting guides are then connected to the bone pins for precise bone resection.
The TMINI system’s first 510(k) clearance is currently for use with the Enovis™ EMPOWR Knee System.
In addition, THINK Surgical is preparing for a new 510(k) submission for its additional implant system, making it compatible with multiple implant manufacturers.
During the process, THINK Surgical quality assurance and regulatory affairs vice-president Meliha Mulalic used her experience to prepare answers to all the questions in the interactive review to help the company seamlessly obtain 510(k) clearance for the TMINI system.
An open implant robotic system TMINI can support different implants from multiple manufacturers and is constantly updating its implant library to appeal to a broader market.
The company plans to reduce resistance to robotics, which it claims stems from disrupted workflows and closed robotic systems. They believe their open-implant robotic system can do this by allowing various manufacturers to be compatible with their devices.
Think Surgical CEO,Stuart Simpson said: “With its small footprint, open implant platform and intuitive workflow, the TMINI system opens up robotic possibilities for more clinics, operating rooms, and surgeons.”
According to GlobalData forecasts, the surgical robotics market was valued at $8.6bn in 2022, and by 2030, it will have expanded at a compound annual growth rate (CAGR) of 8% to $15.8bn.