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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 057 Date of Entry 12/20/2021 
FR Recognition Number 11-391
Standard
ASTM F2722 - 21
Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
Scope/Abstract
1.1 This practice covers a laboratory-based in-vitro method for evaluating the mechanical performance of materials and devices being considered for replacement of the tibio-femoral joint in human knee joint replacement prostheses in mobile bearing knee systems.

1.2 Mobile bearing knee systems permit internal/external rotation to take place on one or both articulating surfaces. Some designs place physical limits or stops to the amount of rotation. Other designs may have increases of a resistance force with increases in rotation.

1.3 Although the methodology describes attempts to identify physiologically relevant motions and force conditions, the interpretation of results is limited to an in-vitro comparison between mobile bearing knee designs and their ability to maintain the integrity of the rotational stop feature and tibial bearing component under the stated test conditions.

1.4 This practice is only applicable to mobile knee tibial systems with a rotational stop.
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
Unclassified Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing Class 3 NRA
Unclassified Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing Class 3 NJL
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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