Merete MECRON™ Cannulated Screw System

Vendor/Manufacturer: Merete GmbH

Product/Product Line: MECRON™ Cannulated Screw System

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: HWC

FDA Classification Product Code Device Name:

Screw, Fixation, Bone

SUBSTANTIALLY EQUIVALENT to the following products:

1. Paragon 28 MONSTER Screw System

2. VILEX/DUVAL/ORTHEX Cannulated Bone Screw, Model F20-XX-00

Device Description:

The MECRON Cannulated Screw System consists of headed and headless bone screws and corresponding washers. The screws are offered in diameters from 2.0mm thru 7.0mm (in 0.5 mm increments) and overall lengths from 8 mm (for smaller diameters) thru 120 mm (for larger diameters). The cannulated screws have self-tapping and self-drilling features and are manufactured from medical grade titanium alloy (per DIN EN ISO 5832-3 and ASTM F136).

Indications for Use:

The MECRON Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the size of the device.