Recognition List Number: 020 Publication Date: 09/09/2008
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 11-191: ISO 14879-1:2000, Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays. (Orthopaedics)
Date of Standard: 2000. |
| 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: |
| Metallic tibial trays used in 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 test method covers procedures for the performance of fatigue testing of metallic tibial trays using a cyclic constant-amplitude force. It applies to tibial trays which cover both the medial and lateral plateaus of the tibia. This test may require modifications to accommodate other tibial tray designs.
Additional information must be provided to document that the design of the product will provide adequate mechanical properties for the particular application. In applications subjected to wear or articulation, additional data may be needed to document resistance to wear and abrasion. |
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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 |
Metal Cemented Constrained Femorotibial Knee Prosthesis |
Class 3 |
KRN |
| |
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 |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3530 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer |
Class 2 |
HRY |
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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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