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Bone Solutions Inc. to file 510(k) applications for bone void filler
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Bone Solutions Inc. announced in a press release it will soon file four 510(k) applications with the FDA related to its OsteoCrete platform. The company has previously received FDA 510(k) clearance for the first application for OsteoCrete as proprietary bone void filler.
OsteoCrete was certified in May 2009 as a bone void filler by the FDA for broad applications in musculoskeletal structure, trauma, bone grafting, and related surgeries. The next 510(k) filings from Bone Solutions Inc. (BSI) will be for maxillofacial applications, use as a bone anchor, cranial applications, and a non-loadbearing spine application, the company reported.
“BSI is now poised not only to roll out its initial product in the United States, but also will also pursue CE Mark certification for European Union sales,” Tom Lally, BSI president, stated in the 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. It is intended to be placed or injected into bony voids or gaps in the long bone and pelvis. These defects may be surgically created osseous defects or osseous defects due to traumatic injury to the bone. It is designed to provide a bone void filler that resorbs and is replaced with bone during the healing process the company noted.