Bone Solutions’ OsteoCrete OK’ed for Intervertebral Body Fusion

Orthobiologics company Bone Solutions has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance of its Mg OsteoCrete for use in the intervertebral body disc space, including cervical, thoracic, and lumbar fusion procedures.
 
According to the company, this is the first and only magnesium-based bone substitute cleared by the FDA for this indication.
 
Mg OsteoCrete is a fast-setting bone substitute that remodels bone over time by way of creeping substitution. The remodeling profile means the material offers support to the defect or void during healing, then transforms into bone at an optimal rate. It’s already cleared for posterolateral spine surgeries.
 
Magnesium oxide’s crystallization reaction and the blend of phosphate-based materials allows for the product’s complete osteoconductivity, according to Bone Support. Post-placement Mg OsteoCrete sets and cures in-situ without migration. The material provokes cell adhesion, proliferation, and formation of the bone extracellular matrix (ECM) by the osteoblasts to promote bone growth.
 
The material is moldable or injectable and coheres and adheres to the area it’s filling. The material is ready after 30 seconds of mixing and is drillable after two minutes. Mg OsteoCrete is also radiopaque.
 
“We are enthusiastic for the opportunity to positively impact more spine procedures with this expanded indication,” said Drew Diaz, CEO of Bone Solutions. “Bone Solutions remains dedicated to improving patient outcomes through our superior magnesium-based orthopedic technologies.”