Metalogix Gains FDA Clearance for Revolution External Plating System

By Julie A. Vetalice

Metalogix was granted FDA 510(k) clearance for the Revolution External Plating System, open ring fixation for long bone fractures, limb lengthening and bone deformity correction. The product will enter limited launch at the start of 3Q19.

The all-in-one system can treat long bone trauma, Charcot, foot and ankle, congenital deformities and pelvic trauma, and is indicated for adult and pediatric subgroups (except newborns). Other indications include stabilization of open and/or unstable proximal and/or distal tibial fractures, hand, foot and long bone fusions, bone or soft tissue deformity correction and fracture neutralization stabilized with limited internal fixation.

“The Metalogix Revolution External Plating System was designed by myself and Bob Wigginton, an international leader in orthopedic product design, after identifying problems with traditional circular fixation systems,” says CEO Douglas Klein. “We focused on posterior freedom and definitive fixation, making it easier for surgeons to manipulate bone and increase range of motion to optimize healing.”

Source: Metalogix


Product Labels: External Fixation, Trauma Ankle/Foot/Toe, Upper Extremity, Lower Extremity

Tags: 510(k) Clearance, Regulatory