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Introduction of New Technologies in Orthopaedic Surgery

Goodman, Stuart B., MD, PhD1,a; Mihalko, William M., MD, PhD2,b; Anderson, Paul A., MD, PhD3,c; Sale, Katherine, MPH4,d; Bozic, Kevin J., MD, MBA5,e

doi: 10.2106/JBJS.RVW.O.00067
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Disclosures

  • ➢ The introduction of new devices, biologics, and combination products to the orthopaedic marketplace is increasing rapidly.
  • ➢ The majority of these new technologies obtain clearance to market by demonstrating substantial equivalence to a predicate (previously approved device) according to the U.S. Food and Drug Administration (FDA) 510(k) process.
  • ➢ Surgeons play a critical role in the introduction of new technologies to patients and must take a leadership role in promoting safe, efficacious, appropriate, and cost-effective care, especially for operative procedures.
  • ➢ Surgeons should monitor and document their patients’ clinical outcomes and adverse events when using new technology, to ensure that the new technology is performing as desired.

1Department of Orthopaedic Surgery, Stanford University School of Medicine, Redwood City, California

2Department of Orthopaedic Surgery & Biomedical Engineering, Campbell Clinic, Memphis, Tennessee

3Department of Orthopaedic Surgery, University of Wisconsin, Madison, Wisconsin

4Department of Research and Scientific Affairs, American Academy of Orthopaedic Surgeons, Rosemont, Illinois

5Department of Surgery and Perioperative Care, Dell Medical School, University of Texas at Austin, Austin, Texas

aE-mail address for S.B. Goodman: goodbone@stanford.edu

bE-mail address for W.M. Mihalko: wmihalko@campbellclinic.com

cE-mail address for P.A. Anderson: anderson@ortho.wisc.edu

dE-mail address for K. Sale: sale@aaos.org

eE-mail address for K.J. Bozic: kevin.bozic@austin.utexas.edu

Copyright © 2016 by The Journal of Bone and Joint Surgery, Incorporated
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