Part B: Supplementary Information Sheet (SIS) |
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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11-311
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Standard | |
ISO 14243-2 Third edition 2016-09-01 Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement |
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Scope/AbstractThis part of ISO 14243 specifies a method of assessment of wear of the tibial component of total knee-joint prostheses using the gravimetric technique for components tested in accordance with ISO 14243-1 or ISO 14243-3 as appropriate. |
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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 |
§888.3480 |
Metal Cemented Constrained Femorotibial Knee Prosthesis
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Class 3
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KRN
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§888.3490 |
Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented
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Class 2
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KMB
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§888.3490 |
Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented
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Class 2
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KTX
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§888.3500 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite
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Class 2
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KYK
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§888.3510 |
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
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Class 2
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KRO
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§888.3520 |
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
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Class 2
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HSX
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§888.3530 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
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Class 2
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HRY
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§888.3550 |
Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal
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Class 3
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KRP
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§888.3550 |
Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer
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Class 2
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KRQ
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§888.3560 |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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Class 2
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JWH
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§888.3560 |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
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Class 2
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MBV
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§888.3565 |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
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Class 2
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MBH
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No CFR citation for the following procodes; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Polymer/Metal/Polymer
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Class 3
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LXY
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No CFR citation for the following procodes; Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
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Class 3
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MBD
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Relevant FDA Guidance and/or Supportive Publications*
Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA, January 16, 2003
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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