| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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055
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Date of Entry 12/21/2020
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FR Recognition Number
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11-374
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| Standard | |
ISO 7207-2 Second edition 2011-07-01
Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials [Including AMENDMENT 1 (2016) and AMENDMENT 2 (2020)] |
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Scope/Abstract| This part of ISO 7207 specifies surface finish requirements for the articulating surfaces of total and partial knee joint prostheses classified in ISO 7207-1. This part of ISO 7207 is intended to provide guidance for periodic validation of production processes. |
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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 |
Prosthesis, Knee, Hinged (Metal-Metal)
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Class 3
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HRZ
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| §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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| §888.3535 |
Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
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Class 2
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NJD
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| §888.3540 |
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
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Class 2
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KRR
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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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| §888.3560 |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
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Class 2
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OIY
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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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| N/A |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Polymer/Metal/Polymer |
Class 3
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LXY
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| N/A |
Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
Class 3
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MBD
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| N/A |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing |
Class 3
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NJL
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| N/A |
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing |
Class 3
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NRA
|
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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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