FDA clears Bone Solutions magnesium-based bone substitute for spinal surgery

Bone Solutions Inc., an innovative orthobiologics technology company based in Colleyville, Texas, has achieved a milestone with the 510(k) clearance of Mg OSTEOCRETE from the U.S. Food and Drug Administration (FDA). This clearance heralds Mg OSTEOCRETE as the first and only magnesium-based bone substitute approved by the FDA for use in the intervertebral body disc space across cervical, thoracic, and lumbar fusion procedures. This expanded indication not only enriches the arsenal available to surgeons but also underscores the potential benefits of magnesium-based technology for patients undergoing spinal surgeries.

Revolutionizing Spine Surgery with Mg OSTEOCRETE

Mg OSTEOCRETE’s proprietary magnesium-based technology sets a new standard in the field of bone regeneration and orthopedic surgery. As a fast-setting bone substitute, Mg OSTEOCRETE remodels into bone over time through a process known as creeping substitution. This capability ensures that the material provides essential support during the critical healing process and then integrates into the natural bone structure at an optimal rate. Already cleared for use in posterolateral spine procedures, this latest FDA clearance extends its application to a broader range of spinal surgeries, offering a promising solution for enhancing patient outcomes.

The Magnesium Difference

Drew Diaz, CEO of Bone Solutions Inc., expressed enthusiasm about the potential impact of this technology on spine procedures, highlighting the company’s commitment to improving patient outcomes through superior magnesium-based orthopedic technologies. The unique crystallization reaction from magnesium oxide and a blend of phosphate-based materials ensures ideal osteoconductivity, setting Mg OSTEOCRETE apart from other bone substitutes. This differentiation lies not only in its material composition but also in its ability to stimulate cell adhesion, proliferation, and the formation of the bone extracellular matrix by osteoblasts, promoting bone growth.

Optimized for Clinical Use

The handling characteristics and formulation of Mg OSTEOCRETE are tailored for clinical applications. Ready for use after just 30 seconds of mixing, the material can be molded or injected, adhering cohesively to the fill area. Its quick-setting nature, combined with radiopacity, allows for efficient post-operative assessment and integration into the surgical workflow.

Nationwide Distribution of Mg OSTEOCRETE and Future Developments

Mg OSTEOCRETE is now being distributed to medical facilities and surgical centers across the United States for immediate clinical use, signifying a significant advancement in the availability of effective bone healing solutions. Bone Solutions Inc. continues to pioneer the development of new orthopedic technologies within its FDA-cleared magnesium-based platform, focusing on addressing complex procedures and reducing healthcare costs.