[Image courtesy of Think Surgical]Think Surgical announced today that the FDA has granted 510(k) clearance for the company’s TMINI Miniature Robotic System (TMINI 1.1).
TMINI 1.1 software delivers new capabilities that enhance surgeon choice throughout the total knee arthroplasty (TKA) procedure. The new TMINI Pro workflow allows for the adjustment and optimization of implant position to meet the patient’s needs. The workflow’s dynamic data capture and real-time feedback allow surgeons to make position adjustments, allowing them to fine-tune implant position and stability.
Fremont, Calif.-based Think Surgical has designed a workflow that can be customized to suit a surgeon’s preferences and implant strategy choices, and users can wirelessly send surgical plan adjustments to the TMINI robot for a seamless experience.
TMINI is equipped with a wireless robotic handpiece to assist surgeons in performing total knee replacement surgery. After CT-based 3D surgical planning, the handpiece automatically compensates for the surgeon’s hand movements and places bone pins along precisely defined planes. Cutting guides are then connected to the bone pins to perform precise bone resections.
The software’s clearance comes just over a year after the FDA first cleared the TMINI system for knee replacement surgery. The company has since added several implant options to the system, including collaborations with Maxx Orthopedics, b-ONE Ortho, Zimmer Biomet and Signature Orthopaedics.
“This software release is a major enhancement to our TMINI robotic system that not only meets our customers’ needs but also differentiates our platform in the industry,” said Stuart Simpson, president and CEO of Think Surgical. “Achieving a second FDA clearance for the TMINI system in less than 15 months is a major achievement for our company. It demonstrates our development capabilities and commitment to innovation as a company dedicated to robotics and digital surgery.”