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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 063 Date of Entry 12/23/2024 
FR Recognition Number 11-412
Standard
ASTM  F3129-24
Standard Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses
Scope/Abstract
1.1 This guide specifies a method to measure the surface features, such as hills and valleys, and to estimate the in vivo material loss from the conical taper junctions, such as the femoral head/stem junction or adapter sleeve from explanted modular hip prosthesis, modular knee, or shoulder joints. This guide is applicable to any articulating bearing material, stem material, and conical taper size. The principles in this guide may be applied to other designs of taper junction, such as the modular stem/neck junction found in some hip joints.

1.2 This guide includes information on how to perform measurements using a Roundness Machine (1-4), Coordinate Measuring Machine (CMM) (5), and Optical Coordinate Measuring Machine (6, 7).2 Other equipment may be used to estimate material loss if the equipment is reliable and accurate enough to provide comparable estimates to the aforementioned equipment.
Note 1: The maximum depth of material loss is sensitive to the number and spacing of data points.

1.3 The measurement techniques described in this standard guide use measurements taken on the surface of the taper using contact stylus and/or optical instruments. The mating materials and geometries in the taper junction can have changed in form, structure, and composition during use. These changes will impact any final estimation. In addition, any estimation of original surface form will also impact any final estimation of material loss. The material loss/corrosion mechanisms in the taper junction can lead to oxide layers or corrosion products on the surface of the taper. These layers can lead to an underestimation of the volume of material loss.

1.4 The explants can have debris or biological deposits on the surfaces of the taper junctions. These deposits can prevent the measurement of the surface of the taper junction, and their effect on the measurement must be considered when deciding the cleaning protocol.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ASTM F3129-16 [Rec# 11-317] will be superseded by recognition of ASTM F3129-24 [Rec# 11-412]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-317] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 11-317] will not be accepted.
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Lindsay Jeffries
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA
  301-796-3740
  Lindsay.Jeffries@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Orthopedic
*These are provided as examples and others may be applicable.
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