| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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046
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Date of Entry 12/23/2016
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FR Recognition Number
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11-319
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| Standard | |
ISO 7206-12 First edition 2016-10-01
Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for acetabular shells |
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Scope/AbstractThis part of ISO 7206 specifies a test method for determining short-term deformation of a press-fit acetabular component for total hip joint replacement under specific laboratory conditions. It also defines the conditions of testing so that the important parameters that affect the components are taken into account and it describes how the specimen is set up for testing. Furthermore, this part of ISO 7206 specifies the test parameters of press-fit acetabular components tested in accordance with this part of ISO 7206.
The described method is intended to be used to evaluate the comparison of various designs and materials used for acetabular components in total hip joint replacement when tested under similar conditions.
The loading of the acetabular components in vivo will, in general, differ from the loading defined in this test method. The results obtained here cannot be used to directly predict in vivo performance.
This part of ISO 7206 does not cover methods of examining the test specimen. |
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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
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| §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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| §888.3310 |
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
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Class 2
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PBI
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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 |
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
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| §888.3360 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
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Class 2
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LWJ
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| N/A |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented |
Class 3
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MRA
|
| N/A |
Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing |
Class 3
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NXT
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| N/A |
Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation |
Class 3
|
OVO
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Relevant FDA Guidance and/or Supportive Publications*
| 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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