1. Scope
This guide covers general guidelines for the physical, chemical, metallurgical, biocompatibility, mechanical and preclinical assessments of metal-on-metal (M-O-M) articulating surface implants in implantable orthopedic and spinal devices to replace a musculoskeletal joint. The M-o-M implants may include hip, shoulder, total disc replacement, elbow, wrist, finger, toe, and ankle joint implant devices.
This guide will be used by producers and users to assess metal-on-metal implants. This guide may also be used by government bodies such as the FDA or CMS to review and assess orthopedic and spinal devices.
Keywords
Cobalt-Chromium;wear;carbides
The title and scope are in draft form and are under development within this ASTM Committee.
Citing ASTM Standards
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