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

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

CHARLOTTE, N.C. – June 5, 2018 – 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,”

The surgeon who utilized Diamond’s faceted bone screw noted that, “stable, durable fixation was paramount to this type of reconstruction. I chose the Diamond threadform for its superior fixation and pullout strength, and for what I like to call its ‘bone friendly’ design. The faceted threadform not only made insertion of the screws easier, but also gave me confidence that the innovative biomechanical features of this technology will help lead to a successful patient outcome.” 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.

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 faceted threadform technology

Diamond Orthopedic is the exclusive provider of faceted threadform technology for orthopedic applications worldwide

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