Stryker Receives FDA 510(k) Clearance to Market Modular Dual Mobility Acetabular (Hip) System MDM™X3® Extends Stryker's Industry-leading Mobile Bearing Hip™ System Portfolio and Makes Dual Mobility Technology Available to a Broader Patient Population
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 flagship mobile bearing product and was developed to enhance joint stability(1). 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(2). Combining an evolution in design with the only anatomic dual mobility acetabular system and its patented X3 Advanced Bearing Technology(3), 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 accommodate multi-directional movement, which provides the potential for greater range of motion(4) and reduced wear(5) compared to competitive fixed implant designs, based on laboratory testing.
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.
About Stryker Orthopaedics
Stryker Orthopaedics is a division of the Stryker Corporation, one of the world's leading medical technology companies. Stryker Orthopaedics offers an extensive orthopaedic product portfolio including hip, knee and upper extremity reconstructive devices, bone cement, trauma implants, bone substitutes and spine systems. For more information about Stryker Orthopaedics, visit: http://www.stryker.com/enus/products/Orthopaedics/index.htm.
Stryker is one of the world's leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company provides innovative orthopaedic implants as well as state-of-the-art medical and surgical equipment to help people lead more active and more satisfying lives. For more information about Stryker, please visit www.stryker.com.
(1) Heffernan, C., Bhimjl, S., MacIntryre, J., et al. (2011). Development and Validation of a Novel Modular Dual Mobility Hip Bearing. ORS Annual Meeting Poster #1165.
(2) Crawford, R., Ranawat, C. S., Rothman, R. H. (2010). Editorial: Metal on Metal: Is It Work the Risk? JOA 25(1): 1-2.
(3) US Patent # 6,174,934, 6,372,814, 6,664,308, 6,818,020, 7,517,919.
(4) Stryker Test Report: RD-06-078.
(5) Herrera, L., Lee, R., Longaray, J. et al. (2010). Edge Loading Wear due to Inclination Angle for Three Contemporary Hip Bearings. Orthopaedic Research Society: 56th Annual Meeting Poster #2259.
SOURCE Stryker Orthopaedics