Recognized Consensus Standards

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

034

Date of Entry 01/30/2014

FR Recognition Number

11-239

Standard

ASTM F2345-03 (Reapproved 2013)
Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads

Scope/Abstract

1.1 These test methods cover the evaluation of the static and cyclic fatigue strength of ceramic modular femoral heads, mounted on a cone as used on the femoral stem of the total hip arthroplasty.

1.2 These test methods were primarily developed for evaluation of ceramic (Specifications F603 and F1873) head designs on metal cones but may have application to other materials.

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FDA recognition of ASTM F2345-03 (Reapproved 2013) [Rec# 11-239] will be superseded by recognition of ASTM F2345-21 [Rec# 11-385]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-239] until December 18, 2022. After this transition period, declarations of conformity to [Rec# 11-239] will not be accepted.

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
§888.3350	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

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
§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
§888.3353	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
§888.3360	Prosthesis, Hip, Femoral Component, Cemented, Metal	Class 2	JDG
§888.3360	Prosthesis, Hip, Hemi-, Femoral, Metal	Class 2	KWL
§888.3360	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Class 2	LWJ
§888.3360	Prosthesis, Upper Femoral	Class 2	JDD
§888.3390	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Class 2	KWY
§888.3310	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Class 2	KWZ
§888.3340	Prosthesis, Hip, Semi-Constrained, Composite/Metal	Class 2	KMC