1.1 This guide covers materials and design recommendations and general test methods for the chemical, mechanical, and preclinical assessment of implantable devices with metal-on-metal or ceramic-on-ceramic articulations intended to replace a hip joint. This guide covers total hip arthroplasty devices with stems that extend or fix within the intramedullary canal and surface replacement systems. Such devices shall have articulating components manufactured from cobalt-28 % chromium-6 % molybdenum (Co28Cr6Mo) alloy (Specifications F75, F799, or F1537), high-purity alumina (ISO 6474-1), or alumina matrix composite ceramics (ISO 6474-2). 1.2 This guide will provide guidance regarding the acetabular component and the articulating surface of both the acetabular component and the head. Acetabular components can be monoblock or a modular component with a separate acetabular shell and acetabular liner. In the case of modular acetabular components, the acetabular liner and the head will currently be Co28Cr6Mo for a metal-on-metal bearing and high-purity alumina or alumina matrix composite ceramics for a ceramic-on-ceramic bearing. Modular acetabular shells are usually Ti-6Al-4V or Co28Cr6Mo alloy. There may be other materials in clinical use, which would also be covered by the recommendations of this guide, but there may be other evaluation methods not in this guide that would be relevant for those materials. Acetabular components may have external coatings or porous structure or both intended for attachment to bone cement or tissue. 1.3 This guide is simply a summary of available test methods found in current standards or the scientific literature. The clinical relevance is unproven. Some of the methods are standard practices that do not have an established precision and bias. Because the clinical relevance has not been established, most of the test methods do not have performance requirements. This guide represents the current knowledge of evaluation methods. This guide does not intend to prevent the use of new methodologies as they are developed. With some implant systems, not all tests may be required. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Keywordsmusculoskeletal joint replacement; orthopedic device; metal-on-metal hip prosthesis; ceramic-on-ceramic hip prosthesis; metal-on-metal Total Hip Arthroplasty; ceramic-on-ceramic Total Hip Arthroplasty; modular acetabular system; cobalt-28% chromium-6% molybdenum alloy; Co28Cr6Mo; Ti-6Al-4V alloy; high-purity alumina; high-purity alumina matrix composite
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