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FDA approves sale of hip replacement system in United States

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Global Orthopaedic Technology recently received 510(k) approval to market and sell its Paragon hip replacement system in the United States.

“We can report that our cementless Paragon hip implant has successfully addressed the shortcomings of existing devices currently in the market, specifically, incorporating tension grooves on the lateral aspect of the stem which reproduces natural physiological bone strain, to enhance the quality of site fixation,” Darren Churchill, chief executive officer of Global Orthopaedic Technology, stated in a company press release. “The FDA’s recent approval is testament to the superior quality of Global’s research and development, design and manufacture of the Paragon, here in Australia, which will deliver a better quality of life to recipients of the implant locally and in the United States.”