Bone Solutions is committed to provide quality medical devices to the global medical device market-place that improve patient care, meet regulatory and customer requirements, while assuring the continual effectiveness and improvement of Bone Solutions’ Quality System.
OsteoCrete® is the only FDA 510(k) cleared mixture with magnesium oxide biomaterial that is injectable, moldable, and biocompatible Bone Void Filler. Our patented proprietary process provides a unique combination of Osteoconductive and high compression strength characteristics producing the ideal Bone Void Filler for bony voids or defects that are not intrinsic to the stability of the bony structure.
Next Generation Biomaterial:
Facts about magnesium:
Synthetic offer freedom from inherent risks of allograft and xenograft products like prions, viruses, extraneous DNA and RNA, and animal antigens. They are often less expensive while providing the same clinical outcome, but all synthetic bone graft materials are not the same. There are those that resorb too quickly and do not provide a scaffold for new vital bone to grow on and into, and there are those that never resorb preventing the implant space from ever becoming all new vital bone. Therefore, attention to detail in the manufacture of bone graft products is essential to create a product that both resorbs and allows complete bone replacement of the implant material with vital bone in an ideal timeframe.
How do we do it
We maintain quality control throughout the process to ensure the best possible characteristics. Other marketers may just market and sell the final product as it arrives at their door and have no part in material production.
Ideal raw materials are necessary to manufacture the best possible bone graft products. Good and/or bad tract minerals and impurities in raw materials can make their way into the final product. Finding new materials without any trace of impurities is not feasible. Knowing what these impurities are and at what level they occur allows these considerations to be interwoven into the final product performance at the outset of manufacturing. Intact, human bone contains carbonate and low levels of minerals that play important and specific roles in bone formation and maintenance. The key is getting the right ones and in the right concentrations. That takes a thorough understanding and a commitment to make the best possible graft material.
Specific characteristics created in manufacturing
Porosity increases surface area of product exposed to cellular action for maximum bioactivity. Micro porosity helps to wick up fluids and the essential growth components carried in them. Macro porosity of the correct dimensions (100-600 microns) encourages cells to grow on and in the pores of particles more than seen in comparable non-porous materials.
Sintering is one of the final stages in manufacturing synthetic bone graft materials, and it is critical to achieve the correct in vivo residence time for the graft material. Minimal or no sintering creates a soft product that will handle poorly and resorb too quickly resulting in a scaffold inadequate for osteoconductivity. The literature defines this as graft failure. Excessive sintering makes a product that is too hard and a product that will not be resorbed in an appropriate time period. Extreme sintering of certain bone graft products can create a product that will never resorb. Incomplete resorption results in a graft site that does not contain the normal ratio of mineral phase to collagen which creates the full strength of natural bone. Additionally, unchanged graft particles may be hard or impossible to drill through and will not accept implants properly.
Case information for figures 1-4
Substituted hydroxyapatites for bone repair. Shepherd JH, Shepherd DV, Best SM. Journal of Material Science : Material Medicine. 2012; DOI 10.1007/S10856-012-4595-2.
Preparation and cellular response of porous A-type carbonated hydroxyapatite nanoceramics LiB, Lino X, Zheng L, He H, Wang H, Fan H, Zhang Z Materials Science and Engineering. 2012, C 32, 929-936.
Fabrication of low-crystalline carbonate apatite foam bone replacement based on phase transformation of calcite foam. Maruta M, Matsuya S, Ishikawa K. Dental Materials Journal. 2011, 30(1): 14-20.
Fabrication of carbonate apatite block based in internal dissolution precipitation reaction of dicalcium phosphate and calcium carbonate. Daitou F, Maruta M, Kawachi G, Tsuru K, Matsuya S, Terada Y, Ishikawa K. Dental Materials Journal. 2010, 29(3). 303-303.
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*All studies summaries are available upon request through customer service.
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