THINK Surgical Inc. has received FDA 510(k) clearance of its TSolution One Total Knee Application for use in total knee arthroplasty, according to a press release.
THINK Surgical worked with MCRA LLC, which provided clinical study management support for the study on the device, as well as assisted in the preparation and submission of the investigational device exemption to the FDA.
“I’d like to thank the team at MCRA for their expertise and support in the successful completion of this groundbreaking clinical trial,” John Hahn, CEO and president of THINK Surgical Inc., said in the release.
According to the release, five surgeons participated in the clinical trial and confirmed the safety and effectiveness of the TSolution One System. The system includes CT-based 3D pre-surgical planning software to allow surgeons to virtually design and prepare a knee replacement plan that is unique for each patient.
“The clinical trial results clearly demonstrated that THINK Surgical’s TSolution One System is going to revolutionize orthopedic care for patients in the U.S.” Iman Ahmad, director of clinical affairs at MCRA, said in the release. “It has been an honor for MCRA to participate in planning and conducting this study and to witness this milestone clearance.”
The device has been actively marketed in Asia Pacific and Europe, according to the release.