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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 057 Date of Entry 12/20/2021 
FR Recognition Number 11-393
Standard
ASTM  F2724-21
Standard Test Method for Evaluating Mobile Bearing Knee Dislocation
Scope/Abstract
1.1 This test method is designed to provide a standardized method to determine the dislocation resistance of mobile bearing knee designs with regard to femoral component disassociation and spin-out/spit-out of the mobile bearing insert.

1.2 Although the methodology described does not replicate all physiological loading conditions, it is a means of in-vitro comparison of mobile bearing knee designs and their ability to resist dislocation of the mobile bearing from the femoral or tibial components under stated test conditions.

1.3 The test method applies only to mobile bearing total knee designs.
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
N/A Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing Class 3 NJL
N/A Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing Class 3 NRA
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
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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