Recognized Consensus Standards

Recognition List Number: 029 Publication Date: 08/20/2012 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 11-239: ASTM F 2345-03 (Reapproved 2008), Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads. (Orthopaedics)

Date of Standard: 2003. 

Address of Standards Organization:

  ASTM International (ASTM)

  100 Barr Harbor Drive

  West Conshohocken, PA 19428-2959

CDRH Office and Division Associated with Recognized Standards:

OFFICE OF DEVICE EVALUATION (ODE)

Devices Affected:

Femoral Components of Total Hip Replacements (THR) and Hemi-Hip Replacements

Processes Affected:

510(k), IDE, HDE, PMA, PDP, Design Controls

Type of Standard:

 Vertical, National, Test Methods

Extent of Recognition:

Complete Standard

This test method covers the evaluation of the static and cyclic fatigue strength of ceramic modular femoral heads. Additional information must be provided to document that the design of the product will provide adequate mechanical properties for the particular application. Additional data must be provided to document resistance to wear and abrasion of the articulation.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
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
Regulation Number	Device Name	Device Class	Product Code
§888.3300	Prosthesis, Hip, Constrained, Metal	Class 3	KXD
Regulation Number	Device Name	Device Class	Product Code
§888.3310	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Class 2	KWZ
Regulation Number	Device Name	Device Class	Product Code
§888.3320	Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	Class 3	JDL
Regulation Number	Device Name	Device Class	Product Code
§888.3330	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Class 3	KWA
Regulation Number	Device Name	Device Class	Product Code
§888.3340	Prosthesis, Hip, Semi-Constrained, Composite/Metal	Class 2	KMC
Regulation Number	Device Name	Device Class	Product Code
§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
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, Calicum-Phosphate	Class 2	MEH
Regulation Number	Device Name	Device Class	Product Code
§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
Regulation Number	Device Name	Device Class	Product Code
§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
Regulation Number	Device Name	Device Class	Product Code
§888.3390	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Class 2	KWY

Relevant Guidance:

Guidance Document for the Preparation of Premarket Notification For Ceramic Ball Hip Systems, January 10, 1995

FDA Technical Contact:

  John Goode

  FDA/CDRH/ODE

  10903 New Hampshire Avenue Building 66, Room 1510

  Silver Spring MD 20993

  301/796-6407

  Email: john.goode@fda.hhs.gov