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Monday, August 15, 2022

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Mg OSTEOINJECT Receives 510(k) Clearance for Expanded Indications

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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