Orthobiologics technology company Bone Solutions has received 510(k) clearance from the US Food and Drug Administration (FDA) for Mg OSTEOCRETE to be used in intervertebral body fusion procedures.
Mg OSTEOCRETE becomes the first magnesium-based bone substitute to receive FDA clearance for use in the intervertebral body disc space, including cervical, thoracic, and lumbar fusion procedures.
It has previously been approved for posterolateral spine procedures.
Bone Solutions CEO Drew Diaz said: “We are enthusiastic about the opportunity to positively impact more spine procedures with this expanded indication.
“Bone Solutions remains dedicated to improving patient outcomes through our superior magnesium-based orthopaedic technologies.”
The magnesium component is what sets Mg OSTEOCRETE apart from other bone substitutes.
Access the most comprehensive Company Profiles
on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Company Profile – free
sample
Your download email will arrive shortly
We are confident about the
unique
quality of our Company Profiles. However, we want you to make the most
beneficial
decision for your business, so we offer a free sample that you can download by
submitting the below form
By GlobalData
Once placed, it sets and cures in situ, preventing migration and encouraging bone growth by stimulating cell adhesion, proliferation, and the formation of bone extracellular matrix by osteoblasts.
The clinical performance of Mg OSTEOCRETE is complemented by its handling characteristics, the company said.
The material, which is ready for use after a 30-second mix, can be moulded or injected and adheres well to the target area.
It sets quickly once implanted and is drillable after only two minutes.
Mg OSTEOCRETE is being distributed to medical facilities and surgical centers in the US, for immediate use in clinical settings.
Focused on developing new orthopaedic technologies within its magnesium-based platform, Bone Solutions works on improving clinical outcomes through orthopaedic implant solutions that are biologically safe and completely resorbable.
