| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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036
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Date of Entry 07/09/2014
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FR Recognition Number
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11-277
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| Standard | |
ISO 7206-6 Second edition 2013-11-15
Implants for surgery - Partial and total hip joint prostheses - Part 6: Determination of endurance properties of head and neck region of stemmed femoral components |
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Scope/AbstractThis part of ISO 7206 specifies test methods and the fatigue performance for the endurance properties, under specified laboratory conditions, of neck region of stemmed femoral components of total hip joint prostheses and stemmed femoral components used alone in partial hip joint replacement. This part of ISO 7206 does not cover the investigation of the performance of the head or the neck-head junction. It is applicable to modular and non-modular designs made of metallic or non-metallic materials.
It also specifies the test conditions so that the important parameters that affect the hip femoral components are taken into account and describes how the specimen is set up for testing. |
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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)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §888.3300 |
Prosthesis, Hip, Constrained, Metal
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Class 3
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KXD
|
| §888.3310 |
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
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Class 2
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KWZ
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| §888.3320 |
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
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Class 3
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JDL
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| §888.3330 |
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
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Class 3
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KWA
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| §888.3340 |
Prosthesis, Hip, Semi-Constrained, Composite/Metal
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Class 2
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KMC
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| §888.3350 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
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Class 2
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JDI
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| §888.3350 |
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented
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Class 2
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OQH
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| §888.3353 |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
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Class 2
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LZO
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| §888.3353 |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
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Class 2
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MAY
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| §888.3353 |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
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Class 2
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MEH
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| §888.3353 |
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
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Class 2
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OQI
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| §888.3358 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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Class 2
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LPH
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| §888.3358 |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
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Class 2
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MBL
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| §888.3358 |
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
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Class 2
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OQG
|
| §888.3360 |
Prosthesis, Upper Femoral
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Class 2
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JDD
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| §888.3360 |
Prosthesis, Hip, Femoral Component, Cemented, Metal
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Class 2
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JDG
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| §888.3360 |
Prosthesis, Hip, Hemi-, Femoral, Metal
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Class 2
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KWL
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| §888.3360 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
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Class 2
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LWJ
|
| §888.3390 |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
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Class 2
|
KWY
|
| N/A |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented |
Class 3
|
LPF
|
| N/A |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented |
Class 3
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MRA
|
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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
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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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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