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FDA clears Stryker Modular Dual Mobility Hip System

Stryker's Orthopaedics Division has received the US Food and Drug Administration 510(k) clearance for MDM X3 Modular Dual Mobility Mobile Bearing Hip System.

MDM X3 is designed to minimize the risks associated with traditional hip replacement surgery and addresses a broader patient population, including both primary and revision total hip arthroplasty candidates.

MDM X3 is a third-generation dual mobility device that allows surgeons to offer the benefits associated with Stryker‘s dual mobility technology to a broader patient population, including those who may benefit from advanced fixation.

MDM X3, similar to company’s ADM X3, is designed to enhance stability and jump distance, which may increase range of motion in specific patients.

Stryker Orthopaedics’ Mobile Bearing Hip is designed to offer the benefits of a large diameter bearing without a metal-on-metal articulation.

The dual points of articulation in dual mobility constructs help to accommodate multi-directional movement, which provides the potential for greater range of motion and reduced wear compared to competitive fixed implant designs, based on laboratory testing.