Bone Solutions Receives 510(k) Clearance for Expanded Indications of Use for Mg OSTEOCRETE in Intervertebral Body Fusion Procedures
Colleyville, TX., February 13, 2024 — OrthoSpineNews — Bone Solutions Inc., an orthobiologics technology company located in Colleyville, Texas, announced today 510(k) clearance of Mg OSTEOCRETE from the U.S. Food and Drug Administration (FDA) for use in the intervertebral body disc space; including cervical, thoracic, and lumbar fusion procedures. This marks the first and only magnesium-based bone substitute to be cleared by the FDA for this application.
This expanded indication allows surgeons and patients to further benefit from the advantages of the Bone Solutions proprietary magnesium-based technology. Mg OSTEOCRETE is a fast-setting bone substitute that remodels into bone over time through creeping substitution. This remodeling profile means that the material provides needed support to the defect or void during the healing process then transforms into bone at an optimal rate. The product is already cleared for use in posterolateral spine procedures.
“We are enthusiastic for the opportunity to positively impact more spine procedures with this expanded indication,” said Drew Diaz, CEO of Bone Solutions Inc. “Bone Solutions remains dedicated to improving patient outcomes through our superior magnesium-based orthopedic technologies.”
The magnesium component of Mg OSTEOCRETE is the significant differentiator from other bone substitutes on the market. The crystallization reaction from magnesium oxide and the blend of phosphate-based materials allows for ideal osteoconductivity of the product. As a result, post-placement Mg OSTEOCRETE sets and cures in situ without migration. The material stimulates cell adhesion, proliferation, and formation of the bone extracellular matrix (ECM) by the osteoblasts, promoting bone growth.
In addition to the superior clinical performance of the material, the handling characteristics and formulation are ideal for clinical use. Ready for use after only 30 seconds of mixing, the material is moldable or injectable and is cohesive and adhesive to the area it is filling. Once implanted, the material sets quickly, is drillable after only two minutes, and is also radiopaque.
Mg OSTEOCRETE is currently being distributed to facilities and surgical centers nationwide for immediate clinical use.
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About Bone Solutions Inc.
Bone Solutions Inc. is a specialized medical device company dedicated to improving clinical outcomes through biologically safe, fully resorbable magnesium-based orthopedic implant solutions, with a focus on addressing complex procedures and cost reduction. The company is developing various new orthopedic technologies within its FDA-cleared magnesium-based platform.
Media Contact: Paul Williams, MediaLine Communications, 310-569-0023
paul@medialinecommunications.com
