Orthofix MJ-FLEX METAIZEAU Nail

Vendor/Manufacturer: Orthofix Srl

Product/Product Line: MJ-FLEX, The New METAIZEAU Nail™

FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3040

FDA Regulation Description Classification Name:

Smooth or threaded metallic bone fixation fastener

FDA Classification Product Code: HTY

FDA Classification Product Code Device Name:

Pin, Fixation, Smooth

SUBSTANTIALLY EQUIVALENT to the following products:

1. OrthoPediatrics PEDIFLEX Flexible Nail System

Device Description:

The Orthofix MJ-FLEX, THE NEW METAIZEAU NAIL™ is an intramedullary implant system specifically designed for Elastic Stable Intramedullary Nailing (ESIN) fracture fixation.

The System consists of implantable components (intramedullary nails) and instrumentation. Nails are supplied in different diameters and lengths, in order to assure compatibility with patient anatomy, and in both Titanium alloy and Stainless Steel materials.

Indications for Use:

The MJ-FLEX, THE NEW METAIZEAU NAIL™ is intended for the treatment of diaphyseal fractures of long bones.

The MJ-FLEX, THE NEW METAIZEAU NAIL™ is indicated to treat:

• upper extremity and clavicle fractures in all patients except newborns and infants;

• lower extremity fractures in pediatric patients, except newborns and infants, where the flexibility of the implant is paramount not to disrupt the growth plate;

• lower extremity fractures in small adults where the medullary canal is narrow.