5th UHMWPE International Meeting Presentation: Regulation of UHMWPE Biomaterials in Total Joint Arthroplasty

  • Reference:
  • Kasser M. Regulation of UHMWPE Biomaterials in Total Joint Arthroplasty. Transactions of the 5th UHMWPE International Meeting, Philadelphia, USA, September 22-23, 2011.
  • Keywords:
  • UHMWPE, FDA, 510(k), crosslinking, Vitamin E
  • Permissions:
  • The conference presentation is made publicly available at www.uhmwpe.org with permission of the speaker.

Abstract

This invited lecture reviews the regulatory pathway for UHMWPE biomaterials for total joint replacement. Dr. Michael Kasser from the FDA starts with an overview of the FDA regulations as they apply to orthopaedic implants. The 510(k) Flowchart is used to illustrate the regulatory pathway for irradiated and thermally treated HXLPEs, as well as the latest generation of HXLPEs containing Vitamin E. The testing requirements that have been required for the FDA to reach a substantial equivalent determination for Vitamin E blended UHMWPEs are outlined in detail.

 

Dr. Michael Kasser received his Ph.D. from the University of Maryland for his research related to the radiation chemistry of UHMWPE. He is a reviewer for the Orthopedic Joint Devices Branch, in the Division of Surgical, Orthopedic, and Restorative Devices, Office of Device Evaluation/CDRH/FDA.

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