The following argument is made by Dr Frederick Matsen, Professor in the Department of Orthopaedics at the University of Washington; a shoulder reconstructive surgery and shoulder arthritis specialist.
How effective is the U.S. Food and Drug Administration (FDA) in assuring safety and effectiveness of shoulder arthroplasty implants? (shoulder arthritis blog)
New joint replacement systems and implants are cleared for clinical use by the Food and Drug Administration (FDA) by what is known as the 510(k) mechanism.
510(k) clearance does not require testing of safety and efficacy in clinical trial...