The Interconnected Ancestral Network of Hip Arthroplasty Device Approval.

Abstract

In the United States, the most overwhelming medical devices, including hip arthroplasty devices, are cleared for human use by demonstration of "substantial equivalence" to a predicate, previously approved marketed device. This study examined the predicate approval lineages of modern hip arthroplasty devices. The FDA 510(k) and premarket approval databases were searched to identify all approved hip arthroplasty devices since the database's inception in May 28, 1976. Ancestral predicate lineages w