Recognized Consensus Standards

Recognition List Number: 020 Publication Date: 09/09/2008

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 11-74: ISO 5838-2:1991, Implants for surgery -- Skeletal pins and wires -- Part 2: Steinmann skeletal pins -- Dimensions. (Orthopaedics)

Date of Standard: 1991.

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)

Devices Affected:

Smooth or threaded fixation pins and wires used with or without external skeletal fixation devices.

Processes Affected:

510(K), Design Controls

Type of Standard:

International, Vertical, Test Methods

Extent of Recognition:

Complete Standard.

Standard covers functional dimensions and considerations for the characterization and comparison of external skeletal fixation devices. 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
§888.3030	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Class 2	KTT

Regulation Number	Device Name	Device Class	Product Code
§888.3040	Pin, Fixation, Smooth	Class 2	HTY
§888.3040	Pin, Fixation, Threaded	Class 2	JDW