Recognition List Number: 022 Publication Date: 09/08/2009
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 11-218: ISO 14243-3:2004, Technical Corrigendum 1 Implants for surgery - Wear of total-knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test. (Orthopaedics)
Date of Standard: 2006. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) |
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| Devices Affected: |
| Total knee replacements (TKR) |
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| Processes Affected: |
| 510(k), HDE, IDE, PMA, PDP, Design Controls |
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| Type of Standard: |
| Vertical, International, Test Methods |
| Extent of Recognition: |
Complete standard
This standard is a technical corrigendum for ISO 14243-3:2004 as it adds a normative reference and identifies a correction to note 2 in clause 7.7. ISO 14243-3:2004 specifies the relative movement between articulating components, the pattern of the applied force, speed and duration of testing, sample configuration and test environment to be used for the wear testing of total knee-joint prostheses in wear-testing machines having axial load control, flexion/extension angular motion control, AP displacement control and tibial rotation control.
Additional information must be provided to document that the design of the product will provide adequate mechanical properties for the particular application. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| Unclassified |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Polymer/Metal/Polymer |
Class 3 |
LXY |
| Unclassified |
Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
Class 3 |
MBD |
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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 |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3480 |
Metal Cemented Constrained Femorotibial Knee Prosthesis |
Class 3 |
KRN |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3490 |
Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented |
Class 2 |
KTX |
| §888.3490 |
Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented |
Class 2 |
KMB |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3500 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite |
Class 2 |
KYK |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3510 |
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
Class 2 |
KRO |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3520 |
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer |
Class 2 |
HSX |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3530 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer |
Class 2 |
HRY |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §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 |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §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/Metal/Polymer |
Class 2 |
JWH |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3565 |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
Class 2 |
MBH |
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| Relevant Guidance: |
| 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 |
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| FDA Technical Contact: |
| John Goode |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1510 |
| Silver Spring MD 20993 |
| 301/796-6407 |
| Email: john.goode@fda.hhs.gov |
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| * In the United States, copies of this standard can be obtained from: |
| American National Standards Institute (ANSI)* |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
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