Genesis Fracture Care G3™ ACTIVE PLATE® Miniature System

Vendor/Manufacturer: Genesis Fracture Care, Inc.

Product/Product Line: G3™ Active Plate® Miniature System

FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3030

FDA Regulation Description Classification Name:

Single/multiple component metallic bone fixation appliances and accessories

FDA Classification Product Code: HRS

FDA Classification Product Code Device Name:

Plate, Fixation, Bone

SUBSTANTIALLY EQUIVALENT to the following products:

1. Zimmer Biomet (Hand Innovations) - Mini Fragment Plates

2. DePuy Synthes - Variable Angle Locking Hand System

3. DePuy Synthes - Small Bone Locking Plating System

4. Small Bone Innovations - SBI K-Wires

5. Wright Medical - WMT Implantable K-Wires

Device Description:

The G3™ Active Plate® Miniature System is a straight plate and locking screw system intended to be used for fracture fixation of the hand and foot. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI), medical grade cobalt chrome alloy (Co28Cr-6Mo) and silicone elastomer in the subject device.

The plate has 8 holes. The plates incorporate link elements, which are constrained within the plate and embedded in an elastomer sheath that is bonded to both the plate and the link element. Once locking screws are inserted, the active elements allow for independent controlled axial translation of the screws. The screws are 1.5 mm diameter and come in lengths ranging from 8 mm to 24 mm.

Indications for Use:

The G3™ Active Plate® Miniature System is intended for fracture fixation in patients 18 years of age and older requiring stabilization of mal-unions, non-unions, osteotomies and repair of closed and open fractures in small bones. The system is indicated for the fixation of small bone fractures including, but not limited to, fractures of the hand, foot, wrist and ankle.