Recognition List Number: 025 Publication Date: 10/04/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 11-223: ISO 14243-2 Second edition 2009-11-15, Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement. (Orthopaedics)
Date of Standard: 2009. |
| 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: |
| International, Vertical, Test Methods |
| Extent of Recognition: |
Complete standard
This standard specifies methods of assessment of wear of the tibial component of total knee-joint prostheses using gravimetric techniques and changes in dimensional form of components tested in accordance with ISO 14243-1 and ISO 14243-3.
Additional information must be provided to document that the design of the product will provide adequate mechanical properties for the particular application. Additional analysis of wear particle's size, distribution and morphology may be needed. |
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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 |
| |
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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