The Interconnected Ancestral Network of Hip Arthroplasty Device Approval.
Ajay PremkumarAndrew ZhuXiaohan YingChristian A PeanNeil P ShethMichael B CrossAlejandro Gonzalez Della VallePublished in: The Journal of the American Academy of Orthopaedic Surgeons (2021)
The lineage of hip arthroplasty device predicates reflects a complex ancestral web of equivalency across a wide range of implants, although their material and design properties may be different. Several currently approved devices were approved on substantial equivalence claims to products that were subsequently recalled from the market for implant design issues. These findings present several policy considerations for regulators, physicians, and the medical device industry.