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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 031 Date of Entry 08/06/2013 
FR Recognition Number 11-253
ASTM F1800-12 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
Scope/Abstract
1.1 This practice covers a procedure for the fatigue testing of metallic tibial trays used in knee joint replacements. This practice covers the procedures for the performance of fatigue tests on metallic tibial components using a cyclic, constant-amplitude force. It applies to tibial trays which cover both the medial and lateral plateaus of the tibia. This practice may require modifications to accommodate other tibial tray designs.

1.2 This practice is intended to provide useful, consistent, and reproducible information about the fatigue performance of metallic tibial trays with one unsupported condyle.

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.
Transition Period
FDA recognition of ASTM F1800-12 [Rec# 11-253] will be superseded by recognition of ASTM F1800-19 e1 [Rec# 11-365]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-253] until July 11, 2021. After this transition period, declarations of conformity to [Rec# 11-253] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§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
§888.3560 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
§888.3480 Metal Cemented Constrained Femorotibial Knee Prosthesis Class 3 KRN
§888.3510 Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Class 2 KRO
§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
IDE/PMA/PDP
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
§888.3565 Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Class 2 MBH
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA: Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses, Issued January 2003.
FDA Technical Contact
 John Goode
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/
  301-796-6407
  john.goode@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Orthopedic
*These are provided as examples and others may be applicable.
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