Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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051
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Date of Entry 01/14/2019
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FR Recognition Number
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11-344
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Standard | |
ASTM F2580-18 Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis |
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Scope/Abstract1.1 This practice covers a procedure for the fatigue testing of metallic femoral hip prostheses used in hip joint replacements. This practice covers the procedures for the performance of fatigue tests on metallic femoral hip stems using a cyclic, constant-amplitude force. It applies to hip prostheses that utilize proximal metaphyseal fixation and are of a modular construct, and it is intended to evaluate the fatigue performance of the modular connections in the metaphyseal filling (that is, proximal body) region of the stem.
1.2 This practice is intended to provide useful, consistent, and reproducible information about the fatigue performance of metallic hip prostheses while held in a proximally fixated manner, with the distal end not held by a potting medium. |
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Extent of Recognition
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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. |
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Public Law, CFR Citation(s) and Procode(s)*
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Regulation Number |
Device Name |
Device Class |
Product Code |
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 |
Regulation Number |
Device Name |
Device Class |
Product Code |
§888.3310 |
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer |
Class 2 |
KWZ |
§888.3310 |
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive |
Class 2 |
PBI |
Regulation Number |
Device Name |
Device Class |
Product Code |
§888.3320 |
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) |
Class 3 |
JDL |
Regulation Number |
Device Name |
Device Class |
Product Code |
§888.3353 |
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented |
Class 2 |
OQI |
§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 |
Regulation Number |
Device Name |
Device Class |
Product Code |
§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 |
§888.3360 |
Prosthesis, Upper Femoral |
Class 2 |
JDD |
Regulation Number |
Device Name |
Device Class |
Product Code |
§888.3300 |
Prosthesis, Hip, Constrained, Metal |
Class 3 |
KXD |
Regulation Number |
Device Name |
Device Class |
Product Code |
§888.3330 |
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) |
Class 3 |
KWA |
Regulation Number |
Device Name |
Device Class |
Product Code |
§888.3340 |
Prosthesis, Hip, Semi-Constrained, Composite/Metal |
Class 2 |
KMC |
Regulation Number |
Device Name |
Device Class |
Product Code |
§888.3350 |
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented |
Class 2 |
OQH |
§888.3350 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
Class 2 |
JDI |
Regulation Number |
Device Name |
Device Class |
Product Code |
§888.3358 |
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented |
Class 2 |
OQG |
§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 |
Regulation Number |
Device Name |
Device Class |
Product Code |
§888.3390 |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
Class 2 |
KWY |
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Non-clinical Information for Femoral Stem Prostheses, September 17, 2007 |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |
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