FDA OKs Stryker’s New MDM X3 Hip System

@font-face { font-family: “Arial”; }@font-face { font-family: “Cambria”; }p.MsoNormal, li.MsoNormal, div.MsoNormal { margin: 0in 0in 0.0001pt; font-size: 12pt; font-family: “Times New Roman”; }div.Section1 { page: Section1; }Announced just prior to the annual meeting of the American Academy of Orthopaedic Surgeons (AAOS) in San Diego, Calif., Stryker Corp.’s Orthopaedics unit received 510(k) clearance from the U.S. Food and Drug Administration (FDA) 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.

FDA 510(k) clearance for the MDM X3 follows the commercial success of the ADM X3 mobile bearing hip system, which launched one year ago and contributed to Stryker’s strong performance in the hip reconstruction market in 2010, company officials said.

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

“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,” said Bill Huffnagle, vice president and general manager, Hip Reconstruction. “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.”

ADM X3 is Stryker’s flagship mobile bearing product and was developed to enhance joint stability. To address limitations in stability, conventional designs focus on the use of metal-on-metal large head technologies, which, based on recent studies, suggest added risk due to metal-on-metal articulation. Combining an evolution in design with the only anatomic dual mobility acetabular system and patented X3 advanced bearing technology, Stryker’s ADM X3 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 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, Stryker officials said.