ASTM F2979-14

Standard Organization:

ASTM F2979-14
Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses

Recognition Date2015-01-27
Recognition List038
Recognition Number11-286
Extent Complete standard
Standards Orgs ASTM ASTM International http://www.astm.org/
STG Orthopedic
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Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

1.1 This guide specifies a method to measure the in-vivo wear of explanted Metal-on-Metal (MoM) and other "hard" (e.g., ceramic) hip components. The guide covers the measurement of acetabular cups and femoral heads using a dimensional change method and is applicable to all prosthetic hip types, including stemmed (modular) and resurfacing hip systems.

1.2 The methods specified in this guide are not applicable for measuring the in-vivo wear from non-articulating surfaces, for example modular connections (at the stem/neck, neck/head or cup liner/shell interface) or at acetabular cup rim.

1.3 The parameters (wear depth and volumetric wear) evaluated and reported in this guide are estimated from the assumed as-manufactured shape of the components. The wear volume is calculated using a numerical integration method and the wear depth is the difference between the assumed as-manufactured shape and the measured surface.

1.4 This guide covers the measurement of the depth of wear and the volumetric wear using a Coordinate Measuring Machine (CMM) and the depth of wear using an Roundness Machine. Other metrology measurement equipment may be used to measure the wear depth or volume if the resolution and accuracy of the measurements are comparable with the instruments detailed in this standard. The measurement and analysis protocols should be based on those described in this standard.

1.5 This guide is applicable to hip joints which are nominally spherical at the time of manufacture. Form deviations resulting from manufacturing or deformation may occur and may necessitate the use of a non-spherical surface to represent the unworn surface of the component. Hip joints designed with asymmetry are considered beyond the scope of this guide, although the principles and techniques may be applicable to the characterization of wear from the articulating surfaces.

1.6 This guide is intended as an extension to ASTM F561 as a Stage II nondestructive test.

1.7 This standard may involve hazardous materials, operations and equipment. As a precautionary measure, explanted devices should be sterilized or disinfected by an appropriate means that does not adversely affect the implant or the associated tissue that may be the subject of subsequent analysis. A detailed discussion of precautions to be used in handling human tissues can be found in ISO 12891-1. 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.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§888.3330 Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Class 3 KWA
§888.3320 Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) Class 3 JDL
Unclassified Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation Class 3 OVO
Unclassified Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented Class 3 LPF
Unclassified Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented Class 3 MRA
Unclassified Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing Class 3 NXT

FDA Guidance:

There is no relevant guidance developed at this time.

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