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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 040 Date of Recognition 08/14/2015 
FR Recognition Number 11-183
Standard
ASTM F1875-98 (Reapproved 2014)
Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface
Scope/Abstract
1.1 This practice describes the testing, analytical, and characterization methods for evaluating the mechanical stability of the bore and cone interface of the head and stem junction of modular hip implants subjected to cyclic loading by measurements of fretting corrosion (1-5).2 Two test methods described are as follows:

1.1.1 Method I-The primary purpose of this method is to provide a uniform set of guidelines for long-term testing to determine the amount of damage by measurement of the production of corrosion products and particulate debris from fretting and fretting corrosion. Damage is also assessed by characterization of the damage to the bore and cone surfaces (4, 5).

1.1.2 Methods II-This method provides for short-term electrochemical evaluation of the fretting corrosion of the modular interface. It is not the intent of this method to produce damage nor particulate debris but rather to provide a rapid method for qualitative assessment of design changes which do not include material changes (1-4).

1.2 This practice does not provide for judgment or prediction of in-vivo implant performance, but rather provides for a uniform set of guidelines for evaluating relative differences in performance between differing implant designs, constructs, or materials with performance defined in the context of the amount of fretting and fretting corrosion. Also, this practice should permit direct comparison of fretting corrosion data between independent research groups, and thus provide for building of a data base on modular implant performance.

1.3 This practice provides for comparative testing of manufactured hip femoral heads and stems and for coupon type specimen testing where the male taper portion of the modular junction does not include the entire hip implant, with the taper portion of the coupon identical in design, manufacturing, and materials to the taper of the final hip implant (4,5).

1.4 Method I of this practice permits simultaneous evaluation of the fatigue strength of a femoral hip stem (in accordance with Practice F1440) and the mechanical stability and debris generated by fretting and fretting corrosion of the modular interface.

1.5 The general concepts and methodologies described in this practice could be applied to the study of other modular interfaces in total joint prostheses.

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.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§888.3390 Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Class 2 KWY
§888.3360 Prosthesis, Hip, Femoral Component, Cemented, Metal Class 2 JDG
§888.3360 Prosthesis, Hip, Hemi-, Femoral, Metal Class 2 KWL
§888.3360 Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Class 2 LWJ
§888.3358 Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Class 2 LPH
§888.3358 Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Class 2 MBL
§888.3353 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Class 2 MAY
§888.3353 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Class 2 LZO
§888.3353 Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Class 2 MEH
§888.3350 Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Class 2 JDI
§888.3340 Prosthesis, Hip, Semi-Constrained, Composite/Metal Class 2 KMC
§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
§888.3310 Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Class 2 KWZ
§888.3300 Prosthesis, Hip, Constrained, Metal Class 3 KXD
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
Relevant FDA Guidance and/or Supportive Publications
Guidance for Industry and FDA Staff: Non-clinical Information for Femoral Stem Prostheses, September 17, 2007

Guidance Document for Testing Non-Articulating, 'Mechanically Locked,' Modular Implant Components, May 1, 1995
FDA Technical Contact
 Terry O. Woods
  FDA/OMPT/CDRH/OSEL/DAM/
  301-796-2503
  terry.woods@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Orthopedic
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