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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Recognition 01/30/2014 
FR Recognition Number 11-222
Standard
ISO 14243-1 Second edition 2009-11-15
Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test
Scope/Abstract
This part of ISO 14243 specifies the flexion/extension relative angular 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 with load control.
Extent of Recognition
Complete standard
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
§888.3565 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
§888.3500 Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite Class 2 KYK
§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
§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
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
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Orthopedic
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