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Mg OSTEOINJECT Receives 510(k) Clearance for Expanded Indications

What To Know

  • The adhesive properties and unique resorption profile of Mg OSTEOINJECT provide stability, increasing cell proliferation and advancing mineralization that results in enhanced bone regeneration in a broad range of orthopedic applications.
  • Mg OSTEOINJECT is the first drillable, adhesive, and injectable bone void filler in the U.

Bone Solutions Inc. (BSI), an orthobiologics technology company located in Colleyville, Texas, announced today that it has received FDA 510(k) clearance for expanded indications for its Mg OSTEOINJECT.

Mg OSTEOINJECT is the first drillable, adhesive, and injectable bone void filler in the U.S. to incorporate magnesium, a critical component for bone health and development.

The expanded indication includes use of the material as an adjunct to hardware fixation by supporting the bone fragments during the surgical procedure. Magnesium-based Mg OSTEOINJECT showed nearly 30% greater anchoring strength compared to traditional PMMA.1

Mg OSTEOINJECT also provides a minimally invasive treatment option for insufficiency and micro fractures via percutaneous skeletal fixation. The adhesive properties and unique resorption profile of Mg OSTEOINJECT provide stability, increasing cell proliferation and advancing mineralization that results in enhanced bone regeneration in a broad range of orthopedic applications.

Mg OSTEOINJECT is currently being distributed to facilities and surgical centers nationwide for immediate clinical use.


Other FDA news items can be found here.

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Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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