Guidance Document for Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone Or Bone Cement

Orthopedic Devices Branch
Division of General and Restorative Devices
Office of Device Evaluation
Center for Devices and Radiological Health
U.S. Food and Drug Administration

For a number of years there has been increasing interest in surface treating orthopedic devices in an attempt to improve implant fixation. The purpose of this document is to recommend to manufacturers of orthopedic devices and sponsors of future premarket notifications (510k), Investigational Device Exemptions (IDE) applicatons, Premarket Approval (PMA) applications, reclassification petitions, and master files, importa nt information that should be provided to the Food and Drug Administration (FDA) in order to evaluate the substantial equivalence and/or safety and effectiveness of modified orthopedic implant surfaces that are in contact with tissue or bone cement (e.g., porous coatings).

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