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 trials (see Shoulder Arthroplasty Device Clearance: An Ancestral Network Analysis). Instead 510(k) clearance requires evidence of “substantial equivalence” to a predicate device, i.e. one that has previously been cleared by the FDA.
Companies use the 510(k) premarket notification pathway for expedient approval of arthroplasty. With the passage of the 21st Century Cures Act, a piece of legislation reducing the rigor and amount of clinical testing required before device clearance, the 510(k) pathway has became further streamlined.
The number of shoulder implants approved by the 510(k) ...
