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PEEK in Arthroplasty Expert Round Table Presentation: FDA Pathway and Preclinical wear testing of PEEK arthroplasty devices

    • Reference:
    • Keith, E. Preclinical wear testing of PEEK arthroplasty devices Mitigation of Potential Concerns. Presented at the PEEK in Arthroplasty Expert Round Table, San Francisco, CA, February 8, 2012.
    • Keywords:
    • PEEK, artificial disc, hip bearing, wear, FDA, IDE, PMA
    • Permissions:
    • The PDF of this presentation is made available on www.medicalpeek.org with the permission of the author.

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Abstract

This presentation clarifies the US regulatory pathway for PEEK arthroplasty bearings as requiring an investigational device exemption (IDE) and premarket approval (PMA). The FDA's current concerns about preclinical testing of PEEK bearings are also summarized.

Erin Keith is the Deputy Director for Science & Regulatory Policy Office of Device Evaluation, Center for Devices & Radiological Health, Food & Drug Administration.