ASTM F2033 - 12

    Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials

    Active Standard ASTM F2033 | Developed by Subcommittee: F04.22

    Book of Standards Volume: 13.01


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    Abstract

    This specification covers the design and dimensional requirements for metallic, ceramic, and polymeric mating bearing surfaces used in total hip joint prostheses and hip endoprostheses, more specifically, hip joint replacements of the ball-and-socket configuration. This specification covers the sphericity, surface finish requirements, and dimensional tolerances for the following: spherical articulating metallic or ceramic femoral heads of total hip joint prostheses; spherical concave mating surface of metallic and ceramic acetabular components, including the inner polymeric bearing surface of bipolar heads; spherical concave mating surface of polymeric acetabular components; and spherical metallic or ceramic femoral heads of hip endoprostheses, and the outer bearing surface of bipolar heads. This specification, however, does not address the tolerance match between the mating bearing surfaces.

    This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

    1. Scope

    1.1 This specification covers the requirements for the mating bearing surfaces of total hip prostheses and hip endoprostheses. More specifically, this specification covers hip joint replacement of the ball-and-socket configuration.

    1.2 This specification covers the sphericity, surface finish requirements, and dimensional tolerances for the spherical articulating metallic or ceramic femoral heads of total hip joint prostheses.

    1.3 This specification covers the sphericity, surface finish requirements, and dimensional tolerances for the spherical concave mating surface of metallic and ceramic acetabular components, including the inner polymeric bearing surface of bipolar heads, and the surface finish requirements and dimensional tolerances for the spherical concave mating surface of polymeric acetabular components.

    1.4 This specification covers the sphericity and surface finish requirements for the spherical metallic or ceramic femoral heads of hip endoprostheses, and the outer bearing surface of bipolar heads.

    1.5 This specification is intended for standard practice regarding the design of total hip joint bearing surfaces. Additionally, the tolerances imposed on the polymeric portion of the bearing surface are intentionally large due to temperature-induced size changes and other manufacturing concerns. Some manufacturing methods or designs may intentionally reduce the diameter of the polymeric bearing to more closely mate with the diameter of the head.

    1.6 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.


    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ISO Documents

    ISO7206-2 Implants for SurgeryPartial and Total Hip Joint ProsthesisPart II: Bearing Surfaces Made of Metallic and Plastics Materials

    ANSI/ASME Document

    ANSI/ASMEB46.1 -1995 Surface Texture


    ICS Code

    ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

    UNSPSC Code

    UNSPSC Code 42321707(Total hip replacement kit or system)


    DOI: 10.1520/F2033-12

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