Prosidyan Announces FDA Clearance of its FIBERGRAFT® BG Matrix for Extremities and Pelvis
Warren, NJ, April 6, 2018: NJ-based Prosidyan (www.prosidyan.com), developer of proprietary fiber-based bioactive glass products, announcedFDA 510(k) clearance of FIBERGRAFT® BG Matrix – Bone Graft Substitute for extremities and pelvis. FIBERGRAFT® BG Matrix is the third-generation product in the company’s FIBERGRAFT® line of bioactive glass fiber-based products. FIBERGRAFT® BG Matrix leverages the direct connectivity of fibers with an exponentially increased surface area and optimized resorption rates delivered using Prosidyan’s proprietary type I collagen based bioactive carrier.
FIBERGRAFT® BG Matrix – Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® BG Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT® BG Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.
ABOUT Prosidyan: Prosidyan is the creator and supplier of the next generation in synthetic bone grafting through its proprietary manufacturing process utilizing microscopic fibers of bioactive glass. For more information about the company and its products, please visit www.prosidyan.com, or call 908.517.3666.