The ShapeMatch Cutting Guides are designed to assist with total knee replacement positioning. Originally, they were recalled because construction may not have been in accordance with preoperative planning parameters and without 510(k) approval, according to the report.
More Articles on Devices:
31 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in March
Regentis Biomaterials Doubles Scope of Orthopedic Implant Trial
FDA Grants 510(k) Clearance to SterEOS Spine Imaging System
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.
