Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

052

Date of Entry 07/15/2019 

FR Recognition Number

11-358

Standard

ISO  14242-4 First edition 2018-05
Implants for surgery - Wear of total hip-joint prostheses - Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading

Scope/Abstract

This document specifies the test conditions to simulate edge loading in hip prostheses due to steep acetabular cup inclination angle and dynamic separation conditions.

This document is used in conjunction with ISO 14242-1 or ISO 14242-3.

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
§888.3300	Prosthesis, Hip, Constrained, Metal	Class 3	KXD
§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
§888.3330	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Class 3	KWA
§888.3340	Prosthesis, Hip, Semi-Constrained, Composite/Metal	Class 2	KMC
§888.3350	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Class 2	JDI
§888.3350	Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented	Class 2	OQH
§888.3353	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Class 2	LZO
§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, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Class 2	MEH
§888.3353	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Class 2	OQI
§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
§888.3358	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Class 2	OQG
§888.3360	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Class 2	LWJ
§888.3390	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Class 2	KWY
§888.3410	Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer	Class 3	KXB
§888.3410	Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented	Class 3	OCG
N/A	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented	Class 3	LPF
N/A	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented	Class 3	MRA
N/A	Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing	Class 3	NXT
N/A	Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation	Class 3	OVO

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

ISO International Organization for Standardization https://www.iso.org/

FDA Specialty Task Group (STG)

Orthopedic

*These are provided as examples and others may be applicable.