The 510(k) ancestry of a metal-on-metal hip implant

New England Journal of Medicine

Volumn 368, Issue 2, 2013, Pages 97-100

  Ardaugh, Brent M ^a   Graves, Stephen E ^b   Redberg, Rita F ^c  

^a BOSTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b FLINDERS UNIVERSITY   (Australia)

^c UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOMEDICAL TECHNOLOGY ASSESSMENT; CLINICAL EFFECTIVENESS; DEVICE APPROVAL; DEVICE SAFETY; EQUIPMENT DESIGN; HIP ARTHROPLASTY; HIP PROSTHESIS; HUMAN; IMPLANT REGISTRY; MEDICOLEGAL ASPECT; METAL IMPLANTATION; PATIENT SAFETY; PRIORITY JOURNAL; QUALITY CONTROL; REOPERATION; RISK BENEFIT ANALYSIS; SHORT SURVEY;

EID: 84872082045     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp1211581     Document Type: Article

References (5)

1. Institute of Medicine. Medical devices and the public's health: the FDA 510(k) clearance process at 35 years. Washington, DC: National Academies Press, 2011.
2. Center for Devices and Radiological Health. CDRH 2012 strategic priorities. Silver Spring, MD: Food and Drug Administration (http://www.fda.gov/ downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/ CDRHVisionandMission/UCM288736.pdf).
3. Ring PA. Ring UPM total hip arthroplasty. Clin Orthop Relat Res 1983;176:115-23.
4. Cabitza P, Percudani W. Long-term results of 2 continuous series of total hip prostheses of the McKee-Farrar metallo-metal type and the Charnley metallo-plastic type. Arch Sci Med (Torino) 1979;136:45-50. (In Italian.)
5. Australian Orthopaedic Association National Joint Replacement Registry. Supplementary report: investigations of prostheses with higher than anticipated rates of revision. Adelaide: Australian Orthopaedic Association, 2012 (http://www.dmac.adelaide.edu.au/aoanjrr/documents/Identified-Prostheses/ Hips/Total%20Conventional%20Hips/3@~Identified%20and%20no%20longer%20used/ ASR-AcetabularProsthesis.pdf).