Recognized Consensus Standards

Recognition List Number: 030 Publication Date: 01/15/2013

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 11-248: ISO 14242-1 Second edition 2012-01-15, Implants for surgery -- Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test. (Orthopaedics)

Date of Standard: 2012.

Address of Standards Organization:

International Organization for Standardization (ISO)*

1, Rue de Varembe

Case Postale 56

CH 1211 Geneva 20, 0

SWITZERLAND

CDRH Office and Division Associated with Recognized Standards:

	OFFICE OF DEVICE EVALUATION (ODE)
	DIVISION OF SURGICAL DEVICES (DSD)

Devices Affected:

Total hip prostheses

Processes Affected:

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

Type of Standard:

Vertical, International, Test Methods

Extent of Recognition:

Complete standard

This standard specifies the relative angular movement between articulating components, the pattern of the applied force, the speed and duration of testing, the sample configuration and the test environment to be used for the wear testing of total hip-joint prostheses.

Additional information must be provided to document that the design of the product will provide adequate mechanical properties for the particular application.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
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

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
§888.3310	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive	Class 2	PBI

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, Semi-Constrained, Metal/Polymer, Uncemented	Class 2	LWJ

Regulation Number	Device Name	Device Class	Product Code
§888.3390	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Class 2	KWY

Regulation Number	Device Name	Device Class	Product Code
§888.3410	Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer	Class 3	KXB
§888.3410	Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented	Class 3	OCG