Metalogix Receives FDA 510(k) Clearance

Metalogix received FDA 510(k) clearance for the Revolution External Plating System, an open ring fixation designed for long bone fractures, limb lengthening and correction of bone deformities.

The Revolution External Plating System is an all-in-one, definitive treatment system for long-bone trauma, charcot, foot and ankle, congenital deformities and pelvic trauma, and indicated for adult and pediatric subgroups, except newborns.

“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.”

Metalogix was founded in 2015 and headquartered in San Antonio, TX. The Revolution External Plating System is entering limited launch in July 2019.

“For years, surgeons have been limited when using external fixation systems – the circular, closed design often made it challenging to provide the highest-level of care to patients,” says James McWilliam, M.D. “This system offers unprecedented versatility in an external fixation system.”

Richard Derner DPM says, “This is a game-changer that will turn the heads of many external fixator users.”

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.