Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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034
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Date of Entry 01/30/2014
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FR Recognition Number
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11-239
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Standard | |
ASTM F2345-03 (Reapproved 2013) Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads |
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Scope/Abstract1.1 These test methods cover the evaluation of the static and cyclic fatigue strength of ceramic modular femoral heads, mounted on a cone as used on the femoral stem of the total hip arthroplasty.
1.2 These test methods were primarily developed for evaluation of ceramic (Specifications F603 and F1873) head designs on metal cones but may have application to other materials. |
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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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Transition Period
FDA recognition of ASTM F2345-03 (Reapproved 2013) [Rec# 11-239] will be superseded by recognition of ASTM F2345-21 [Rec# 11-385]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-239] until December 18, 2022. After this transition period, declarations of conformity to [Rec# 11-239] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§888.3300 |
Prosthesis, Hip, Constrained, Metal |
Class 3 |
KXD |
§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 |
§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 |
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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 |
§888.3320 |
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) |
Class 3 |
JDL |
§888.3330 |
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) |
Class 3 |
KWA |
§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 |
§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 |
§888.3390 |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
Class 2 |
KWY |
§888.3310 |
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer |
Class 2 |
KWZ |
§888.3340 |
Prosthesis, Hip, Semi-Constrained, Composite/Metal |
Class 2 |
KMC |
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Relevant FDA Guidance and/or Supportive Publications*
Guidance Document for the Preparation of Premarket Notification For Ceramic Ball Hip Systems, January 10, 1995 |
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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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