Dallas, Texas company Bone Solutions has gained US FDA 510(k) clearance for OsteoCrete, which it claims is the world's first magnesium-based bone void filler. The mouldable, bioabsorbable filler is intended to be injected into bone voids, including osseous defects created surgically or from traumatic injury to the bone. It is eventually resorbed and replaced with bone during the healing process. The first device in Bone Solutions' pipeline, OsteoCrete has been cleared for use in the pelvis and long bones. The firm intends to seek further clearance for filler for applications in cranial and maxillofacial surgery, non-load-bearing spine applications, and as a bone anchor and cement.
US approval for OsteoCrete
Dallas, Texas company Bone Solutions has gained US FDA 510(k) clearance for OsteoCrete, which it claims is the world's first magnesium-based bone void filler. The mouldable, bioabsorbable filler is intended to be injected into bone voids, including osseous defects created surgically or from traumatic injury to the bone. It is eventually resorbed and replaced with bone during the healing process. The first device in Bone Solutions' pipeline, OsteoCrete has been cleared for use in the pelvis and long bones. The firm intends to seek further clearance for filler for applications in cranial and maxillofacial surgery, non-load-bearing spine applications, and as a bone anchor and cement.
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