The FDA provided Think Surgical 510(k) clearance to market its TSolution One total knee application for total knee arthroplasty in the U.S.
Four insights:
1. TSolution One features 3D preoperative surgical planning technology, enabling surgeons to prepare a virtual plan for patients' knee replacement procedures.
2. Five surgeons participated in the clinical trial, which achieved 100 percent retention of the 115 enrolled patients.
3. Think Surgical is a client of MCRA, a medical device advisory firm and clinical research organization.
4. MCRA provided clinical study management support and assisted Think Surgical in submitting the device's IDE to the FDA.