| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
034
|
Date of Entry 01/30/2014
|
|
FR Recognition Number
|
11-232
|
| Standard | |
ISO 7207-1 Third edition 2007-02-01
Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions |
|
Scope/Abstract| This part of ISO 7207 classifies femoral, tibial and patellar components for knee joint prostheses in which the bearing surfaces of one or more compartments of the knee are replaced. It also gives definitions of components and the designation of dimensions. |
|
| Extent of Recognition
|
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. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §888.3480 |
Prosthesis, Knee, Hinged (Metal-Metal)
|
Class 3
|
HRZ
|
| §888.3480 |
Metal Cemented Constrained Femorotibial Knee Prosthesis
|
Class 3
|
KRN
|
| §888.3490 |
Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented
|
Class 2
|
KMB
|
| §888.3490 |
Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented
|
Class 2
|
KTX
|
| §888.3500 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite
|
Class 2
|
KYK
|
| §888.3510 |
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
|
Class 2
|
KRO
|
| §888.3520 |
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
|
Class 2
|
HSX
|
| §888.3530 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
|
Class 2
|
HRY
|
| §888.3535 |
Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
|
Class 2
|
NJD
|
| §888.3540 |
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
|
Class 2
|
KRR
|
| §888.3550 |
Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal
|
Class 3
|
KRP
|
| §888.3550 |
Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer
|
Class 2
|
KRQ
|
| §888.3560 |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
Class 2
|
JWH
|
| §888.3560 |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
|
Class 2
|
MBV
|
| §888.3560 |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
|
Class 2
|
OIY
|
| §888.3565 |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
|
Class 2
|
MBH
|
| N/A |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Polymer/Metal/Polymer |
Class 3
|
LXY
|
| N/A |
Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
Class 3
|
MBD
|
| N/A |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing |
Class 3
|
NJL
|
| N/A |
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing |
Class 3
|
NRA
|
|
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. |
|
| FDA Technical Contact
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
|
|
