Think Surgical gains clearance for total knee replacement system

The FDA provided Think Surgical 510(k) clearance to market its TSolution One total knee application for total knee arthroplasty in the U.S.

Advertisement

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.

More articles on devices:
Orthofix’s M6-C cervical disc in 2019: 7 key developments
Dr. Robert Brady: How the 2020 CMS final rule will affect the spine field
How OrthoNY is trying to solve its recruiting problem

At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.

Register to Attend Webinar

160 ambulatory leaders just ranked the EHR as the single system most overdue for AI reinvention

Tuesday, August 11
12:00 PM - 1:00 PM CDT

Presenter: Gautam Shah, MBA, FACHDM, NextGen Healthcare

Advertisement

Next Up in Spinal Tech

Advertisement

Comments are closed.