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Stryker Receives FDA 510(k) Clearance to Market Modular Dual Mobility Acetabular (Hip) System

February 11, 2011 By Bio-Medicine.Org

MAHWAH, N.J., Feb. 11, 2011 /PRNewswire/ — Stryker
Corporation’s (NYSE:
SYK
) Orthopaedics Division today announced U.S. Food and Drug
Administration 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.

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 one year
ago and contributed to Stryker’s strong performance in the hip
reconstruction market in 2010.

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.(1)

“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, Stryker Orthopaedics. 
“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.”

ADM X3 Mobile Bearing Hip System is Stryker’s fl

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SOURCE

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