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Magnesium-based bone void filler receives FDA 510(k) clearance
Bone Solutions Inc. (BSI) officials announced Monday that OsteoCrete, the company’s magnesium-based proprietary bone void filler, received FDA 510(k) clearance.
Company officials hope the approval will trigger BSI’s long-term plan to establish itself as a dominant adhesive technology within the orthopedic industry.
“This is a significant milestone in our strategy to generate a pipeline of products from our patented magnesium-based technology for surgeries at hospitals, clinics and other private surgical centers within the orthopedic industry,” Tony Copp, PhD, executive vice president and chief operating officer for BSI, said in a press release.
OsteoCrete is a biocompatible magnesium-based bone void filler that is both injectable and moldable. It is indicated for bony voids or defects that are not intrinsic to the stability of the bony structure and is intended to be injected into bony voids or gaps of the skeletal system, providing a filler that resorbs and is replaced with bone during the healing process, according to the release.
OsteoCrete is approved for use in the long bone and pelvis in osseous defects created through either surgical or traumatic means. According to Copp, BSI has plans to pursue approval for further uses.
“In the future, we intend to seek further clearance of OsteoCrete for applications in cranial surgery, maxillofacial surgery, non-load-bearing spine applications, and as a bone anchor and bone cement,” he said.
According to BSI, the “deficiencies” of modern calcium-based bone fillers result in lower surgical success rates and higher research and development costs. The recently approved magnesium-based technology, however, provides “significant compressive strength” and “pH-neutral qualities that make it ideal as a delivery system for possible future applications,” according to the press release.
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