New England Journal of Medicine · 2013 · 122 citations · 1 references
MedicineOrthopaedic SurgeryOrthopedic SurgeryImplant SurgeryMedical Device LawOrthopedicsDevice DesignImplant DesignImplantable Biomedical DevicesMedical Device Classification510(K) ClearanceFda RegulationMetallic ImplantsOrthopaedic ImplantsOrthopedic ImplantsSubstantial Equivalence DeterminationSubstantial Equivalence Review
Medical device makers have been able to obtain FDA clearance by claiming substantial equivalence to earlier devices (or parts thereof) that may have been cleared the same way. The ancestry of a problematic metal-on-metal hip implant includes 95 different devices.
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Ring UPM Total Hip Arthroplasty
P. A. RING · Clinical Orthopaedics and Related Research · 1983 · 49 citations