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news.Etex, an orthopedic biomaterials company, has obtained FDA 510k clearance for 1cc and 2.5cc sizes of Beta-bsm injectable paste and Gamma-bsm moldable putty to complement the existing 5cc and 10cc sizes. Both products are bone substitute materials based on the company's proprietary nanocrystalline calcium phosphate technology.
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According to Etex, Beta-bsm and Gamma-bsm set hard to provide an optimal osteoconductive scaffold that mimics the nanocrystalline structure of human bone. Smaller sizes were developed in direct response to the needs of the small bone market.
Beta-bsm injectable paste and Gamma-bsm moldable putty are intended for use in filling bone voids or defects of the skeletal system (including extremities, pelvis, and spine) that are not intrinsic to the stability of the bone structure, the company said.
Brian Ennis, CEO of Etex, said: “Etex is proud of our product development approach, driven by direct customer input. We are excited to offer state of the art bone graft substitutes, formulated for optimal performance and patient outcomes, in sizes complimentary to extremity surgery.”