Recognized Consensus Standards

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

056

Date of Entry 06/07/2021 

FR Recognition Number

11-384

Standard

ASTM F3446-20
Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator

Scope/Abstract

1.1 This test procedure provides a method of evaluating the frictional torque and friction factor of artificial hip joint bearings used in Total Hip Replacement systems. The method presented here was based on a published study, first as a conference paper in 2008 (1)2 and then as a peer-reviewed journal paper (2). The method is compatible with and is capable of being carried out during actual wear testing of total hip replacement implants on wear simulators equipped with multiple degrees of freedom force and moment sensors.

1.2 Although the methodology described does not replicate all physiological loading conditions, it is a means of in-vitro comparison of the frictional torque and friction factor of artificial hip joint bearings used in Total Hip Replacement systems under the stated test conditions.

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
§888.3353	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Class 2	OQI
§888.3353	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	Class 2	MAY
§888.3353	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Class 2	LZO
§888.3353	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Class 2	MEH
Unclassified	Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation	Class 3	OVO
Unclassified	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented	Class 3	LPF
Unclassified	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented	Class 3	MRA
Unclassified	Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing	Class 3	NXT
§888.3300	Prosthesis, Hip, Constrained, Metal	Class 3	KXD
§888.3330	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Class 3	KWA
§888.3350	Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented	Class 2	OQH
§888.3350	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Class 2	JDI
§888.3358	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Class 2	OQG
§888.3358	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Class 2	LPH
§888.3358	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Class 2	MBL
§888.3310	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Class 2	KWZ
§888.3310	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive	Class 2	PBI
§888.3320	Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	Class 3	JDL
§888.3340	Prosthesis, Hip, Semi-Constrained, Composite/Metal	Class 2	KMC
§888.3410	Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer	Class 3	KXB
§888.3410	Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented	Class 3	OCG

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.