ISO 5838-2 First edition 1991-01-15

Standard Organization:

ISO 5838-2 First edition 1991-01-15
Implants for surgery -- Skeletal pins and wires -- Part 2: Steinmann skeletal pins -- Dimensions

Recognition Date	2014-01-30
Recognition List	034
Recognition Number	11-74
Extent	Complete standard
Standards Orgs	ISO International Organization for Standardization https://www.iso.org/
STG	Orthopedic
FDA Tech	Jonathan Peck FDA/OMPT/CDRH/ODE/DOD/PSDB/ 301-796-5650 jonathan.peck@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

This part of ISO 5838 specifies the dimensions of Steinmann skeletal pins. Material and mechanical requirements are covered by ISO 5838-1.

NOTE 1 Attention is drawn to the possible need for different designs of points depending on such factors as the method of insertion, and the site of insertion, i.e. whether the bone is cancellous or cortical.

Code of Federal Regulations:

Regulation Number	Device Name	Device Class	Product Code
§888.3040	Pin, Fixation, Smooth	Class 2	HTY
§888.3040	Pin, Fixation, Threaded	Class 2	JDW
§888.3030	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Class 2	KTT

FDA Guidance:

Reviewers Guidance Checklist for Orthopedics External Fixation Devices, 2/21/97