| ASTM F1875-98 (Reapproved 2014) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface |
| Recognition Date | 2015-08-14 |
| Recognition List | 040 |
| Recognition Number | 11-183 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | Orthopedic |
| FDA Tech | Terry O. Woods FDA/OMPT/CDRH/OSEL/DAM/ 301-796-2503 terry.woods@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| 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 |
| 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 |