Stryker VariAx 2 System

Vendor/Manufacturer: Stryker GmbH

Product/Product Line: VariAx 2 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. DePuy ALPS Small Bone Locked Plating System

2. Stryker VariAx 2 System

Device Description:

VariAx 2 is a system used for internal fixation applications and is composed of sterile and nonsterile screws, washers, and instruments. In addition to independent use, screws of this system are also used with compatible, internal fixation plating systems. These devices are made of titanium alloy, with Type III anodization, and are available in a variety of sizes and diameters, as well as locking and non-locking types.

This submission builds on K140769 by simplifying and clarifying the indications statement, and by expanding the treatment population to include pediatric patients.

Indications for Use:

The VariAx 2 System is indicated for adult and pediatric patients, where the implant would not cross open growth plates, for the treatment of normal or osteopenic bone for the following conditions or procedures:

• Fracture fixation, including single, segmental, and comminuted fractures

• Revision, including nonunion and malunion

• Intra- and extra-articular fractures

• Compression fracture

• Displaced fracture

• Reconstruction

• Replantation

• Arthrodesis

• Osteotomy