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Stryker’s orthopedic division receives FDA 510(k) clearance to market modular dual mobility acetabular system

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Stryker Corporation’s Orthopaedics Division announced it has received FDA 510(k) clearance for its MDM X3 Modular Dual Mobility Mobile Bearing Hip System. MDM X3 is an addition to the company’s portfolio of next-generation technologies designed to minimize the risks traditionally associated with hip replacement surgery and address a broader patient population, including both primary and revision total hip arthroplasty candidates, according to a company press release.

FDA 510(k) clearance for the MDM X3 Mobile Bearing Hip System follows the significant commercial success of the company’s innovative ADM X3 Mobile Bearing Hip System which launched 1 year ago and contributed to Stryker’s strong performance in the hip reconstruction market in 2010, the company stated.

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. Like Stryker Orthopaedics’ ADM X3, MDM X3 is designed to enhance stability and jump distance, which may increase range of motion in specific patients, according to the release

“MDM X3 builds on the significant success we’ve achieved with our Mobile Bearing Hip portfolio and provides surgeons with the versatility to bring the benefits of dual mobility constructs to a greater range of patients,” Bill Huffnagle, vice president and general manager, hip reconstruction, Stryker Orthopaedics, noted. “At Stryker Orthopaedics, we’re continually focused on providing our surgeon customers with innovative designs and technologies to address the wide breadth of reconstructive challenges they face clinically. The launch of MDM X3 reflects our commitment to improving patient outcomes through enhanced technologies.”

The 510(k) clearance of MDM underscores Stryker Orthopaedics’ intention to lead the market in the mobile bearing hip category with products that address the limitations of competitive hip products and highlights the significant investments Stryker continues to make in its hip business, Stryker stated in the release