Document Detail

Regulation of UHMWPE biomaterials in total hip arthroplasty.
MedLine Citation:
PMID:  22987363     Owner:  NLM     Status:  Publisher    
This manuscript provides a brief history of the development of ultrahigh molecular weight polyethylene (UHWMPE) biomaterials and how the U.S. Food and Drug Administration (FDA) regulates medical devices. The flowchart used to decide whether a device is medium or high risk, known as the 510(k) flowchart, is illustrated by taking several examples through the flowchart. In order to demonstrate how changes to UHWMPE material used in the acetabular liners of total hips have been regulated, two major modifications to UHMWPE, highly crosslinked polyethylene and Vitamin E polyethylene, are taken through the flowchart. This manuscript describes the testing that has been provided to demonstrate safety and effectiveness of these modifications, as well as an explanation why the testing was supplied to the FDA. © 2012 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2012.
Michael J Kasser
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-9-15
Journal Detail:
Title:  Journal of biomedical materials research. Part B, Applied biomaterials     Volume:  -     ISSN:  1552-4981     ISO Abbreviation:  J. Biomed. Mater. Res. Part B Appl. Biomater.     Publication Date:  2012 Sep 
Date Detail:
Created Date:  2012-9-18     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101234238     Medline TA:  J Biomed Mater Res B Appl Biomater     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012 Wiley Periodicals, Inc.
Orthopedic Joint Devices Branch, Office of Device Evaluation, Food and Drug Administration, Silver Spring, Maryland.
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