Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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040
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Date of Entry 08/14/2015
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FR Recognition Number
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11-293
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Standard | |
ASTM F2582-14 Standard Test Method for Impingement of Acetabular Prostheses |
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Scope/Abstract1.1 This test method covers a procedure to evaluate acetabular component fatigue, deformation, and wear and femoral head assembly dislocation under dynamic impingement conditions.
1.2 This test method can be used to evaluate single-piece acetabular prostheses, modular prostheses, and constrained prostheses manufactured from polymeric, metallic, or ceramic 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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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, Ceramic-On-Metal Articulation |
Class 3 |
OVO |
Unclassified |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented |
Class 3 |
MRA |
Unclassified |
Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing |
Class 3 |
NXT |
§862.1770 |
Conductivity Rate, Urea Nitrogen |
Class 2 |
LFP |
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 |
§888.3310 |
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 |
§888.3330 |
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) |
Class 3 |
KWA |
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 |
§888.3353 |
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 |
§888.3358 |
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 |
§888.3410 |
Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer |
Class 3 |
KXB |
§888.3410 |
Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented |
Class 3 |
OCG |
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 |
§888.3360 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented |
Class 2 |
LWJ |
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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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