Think Surgical received CE Mark approval for its TSolution One Surgical System, a surgical robot for total knee arthroplasty.
Here are five takeaways:
1. TSolution One enables surgeons to create a patient's personalized pre-surgical joint replacement plan by using 3-D planning and the system's implant library.
2. During the surgery, TSolution One executes the patient's individual plan by removing the diseased bone as well as prepping the bone cavity and joint surface.
3. Think Surgical's robot improves joint replacement implant fit and alignment, leading to reduced postoperative pain, complications and improved patient function.
4. TSolution One was first introduced to the European market in 2015 when it received CE Mark approval for total hip arthroplasty. The system has 510(k) clearance for total hip arthroplasty in the U.S. and is enrolled in clinical trials to receive clearance for total knee arthroplasty.
5. The surgical device received clearance for total hip and knee arthroplasty in Korea and Israel earlier this year.