Diamond Orthopedic Announces 510(k) Clearance for Sterile Faceted Screw Technology

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FDA clearance achieves an important milestone in Diamond’s progress to partner with ambulatory surgery centers around the United States.

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We have achieved an important milestone in our value proposition to the orthopedic industry. We are now in a position to provide sterile products to healthcare providers to help them compete in an environment where supply chain management and cost containment are a continual challenge

Diamond Orthopedic announced today that it has received FDA 510k clearance for sterile packaged faceted bone screws in headless compression, cortex, and cannulated screws and pins and guidewires.

“With this new FDA clearance, we have achieved an important milestone in our value proposition to the orthopedic industry. We are now in a position to provide sterile products to healthcare providers to help them compete in an environment where supply chain management and cost containment are a continual challenge,” says Diamond Orthopedic CEO Roy Bivens. “Further, we believe that our offer is an attractive option where bundled payments are in play.”

The approval is a major step toward Diamond’s strategic goal to penetrate ambulatory surgery center markets, and the orthopedic group networks within them. Sterile products enable providers to reduce sterilization requirements that can be cumbersome and costly to manage.

Diamond’s patented faceted screw design allows surgeons to insert screws into bone with less torque, thereby reducing the potential for microfractures. The faceted design also exhibits better purchase at the bone-screw interface and reduced compressive stress as compared to traditional, helical screws.

Diamond Orthopedic will be attending this year’s 7th Annual Extremity Summit from June 8-10, 2018 in White Sulphur Springs, WV.

About Diamond Orthopedic
Diamond Orthopedic, LLC, headquartered in Charlotte, NC, is a medical device company that offers a revolutionary fixation technology to achieve better patient outcomes at a lower total cost. Diamond Orthopedic is the exclusive provider of faceted threadform technology for orthopedic applications worldwide. With proven superiority over traditional helical threadforms, Diamond Orthopedic is the new fixation standard in orthopedics.

Media Contact:
Guillaume Viallaneix
MedTech Momentum
Phone: 407-960-2994
Email: guillaume(at)medtechmomentum(dot)com

Diamond Orthopedic Contact:
1600 Camden Road
Charlotte, NC, 28203
Phone: 704-585-8270
Email: info(at)diamondortho(dot)com

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Jonathan Crumpler
@DiamondOrthoped
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