ISO 14879-1 First edition 2000-06-01

Standard Organization:

ISO 14879-1 First edition 2000-06-01
Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays

Recognition Date2014-01-30
Recognition List034
Recognition Number11-191
Extent Complete standard
Standards Orgs ISO International Organization for Standardization https://www.iso.org/
STG Orthopedic
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Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

This part of ISO 14879 specifies a test method for determining the endurance properties, under specified laboratory conditions, of tibial trays used in knee-joint prostheses to support and secure the plastics articulating surface. It applies to tibial trays which cover both the medial and lateral plateaux of the tibia.

The test method does not apply to tibial components manufactured solely from plastics materials.

This part of ISO 14879 does not cover methods of examining and reporting the final condition of the test specimen; these may be the subject of agreement between the test laboratory and the parties submitting the specimen for test.

Code of Federal Regulations:

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
§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
§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
§888.3530 Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Class 2 HRY
§888.3520 Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Class 2 HSX
§888.3510 Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Class 2 KRO
§888.3480 Metal Cemented Constrained Femorotibial Knee Prosthesis Class 3 KRN
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

FDA 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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