title: Introduction of New Technologies in Orthopaedic Surgery.
abstract: 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.
authors.affiliation: Department of Orthopaedic Surgery, Stanford University School of Medicine, Redwood City, California.
authors.forename: Stuart B
authors.initials: SB
authors.lastname: Goodman
authors.affiliation: Department of Orthopaedic Surgery & Biomedical Engineering, Campbell Clinic, Memphis, Tennessee.
authors.forename: William M
authors.initials: WM
authors.lastname: Mihalko
authors.affiliation: Department of Orthopaedic Surgery, University of Wisconsin, Madison, Wisconsin.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Anderson
authors.affiliation: Department of Research and Scientific Affairs, American Academy of Orthopaedic Surgeons, Rosemont, Illinois.
authors.forename: Katherine
authors.initials: K
authors.lastname: Sale
authors.affiliation: Department of Surgery and Perioperative Care, Dell Medical School, University of Texas at Austin, Austin, Texas.
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Bozic
mesh_terms: D018795:Device Approval; D006801:Humans; D019637:Orthopedic Procedures / Q000639:trends*; D009985:Orthopedics; D014481:United States; D014486:United States Food and Drug Administration