0
RESEARCH PAPERS: Medical Devices and Sporting Equipment

Preclinical Evaluation of Orthopaedic Implants

[+] Author and Article Information
G. Piotrowski

University of Florida, Gainesville, Fla.

J. H. Butler

Oak Ridge National Laboratories, Oak Ridge, Tenn.

D. C. Richardson

Food and Drug Administration, Silver Spring, Md.

J. Mech. Des 102(4), 655-662 (Oct 01, 1980) (8 pages) doi:10.1115/1.3254802 History: Received August 01, 1980; Online November 17, 2009

Abstract

The Medical Device Amendments to the Food, Drug, and Cosmetics Act mandates that substantially new devices be subjected to study and testing prior to the commencement of clinical trials. The proposed outline for preclinical analysis, testing, and evaluation of orthopaedic implants is intended to guide the designer in defining what the limits of understanding are and, within those limits, to minimize the risk to implant recipient. The process of design qualification and verification is broken down into seven major steps: Problem Definition, Underlying Assumptions, Material Selection, Engineering Analysis, Correlation of Demand to Capabilities, Analytical Estimate of Performance and Experimental Verification of Performance. The discussion of each of these topics focuses on the type of information needed for each activity. Thus, these guidelines present a framework for the rational innovation and design of orthopaedic implants which minimizes the risk to patients involved in clinical trials.

Copyright © 1980 by ASME
Your Session has timed out. Please sign back in to continue.

References

Figures

Tables

Errata

Discussions

Some tools below are only available to our subscribers or users with an online account.

Related Content

Customize your page view by dragging and repositioning the boxes below.

Related Journal Articles
Related eBook Content
Topic Collections

Sorry! You do not have access to this content. For assistance or to subscribe, please contact us:

  • TELEPHONE: 1-800-843-2763 (Toll-free in the USA)
  • EMAIL: asmedigitalcollection@asme.org
Sign In