Bone Solutions, a company specializing in orthobiologics technology located in Colleyville, Texas, announced today that its product, Mg OSTEOCRETE, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use in intervertebral body disc space fusion procedures, including cervical, thoracic, and lumbar fusion procedures. This clearance signifies a milestone as Mg OSTEOCRETE becomes the first magnesium-based bone substitute to be approved by the FDA for this specific application.
Mg OSTEOCRETE is known for its fast-setting properties and its ability to transform into bone over time through a process known as creeping substitution. This unique feature provides essential support to the affected area during the healing process and gradually transitions into bone tissue. The product has already been approved for use in posterolateral spine procedures. One of the distinguishing features of Mg OSTEOCRETE is its magnesium component, which sets it apart from other bone substitutes currently available in the market.
The combination of magnesium oxide and phosphate-based materials in Mg OSTEOCRETE facilitates optimal osteoconductivity, promoting cell adhesion, proliferation, and the formation of the bone extracellular matrix by osteoblasts, thereby encouraging bone growth. Moreover, Mg OSTEOCRETE offers excellent handling characteristics, being ready for use after just 30 seconds of mixing. It can be molded or injected into place, adhering seamlessly to the target area. Once implanted, the material sets rapidly, becoming drillable after only two minutes, and is also radiopaque, ensuring visibility during procedures. The expanded indication for Mg OSTEOCRETE represents a significant advancement in orthobiologics, offering surgeons and patients a promising option for intervertebral body disc space fusion procedures.
Source: https://www.businesswire.com/news/home/20240213202729/en/Bone-Solutions-Receives-510-k-Clearance-for-Expanded-Indications-of-Use-for-Mg-OSTEOCRETE-in-Intervertebral-Body-Fusion-Procedures
