Prosidyan Announces FDA 510(k) clearance of FIBERGRAFT™ BG Putty – Bone Graft Substitute
Warren, NJ, 3/25/15: NJ-based Prosidyan™ (www.prosidyan.com), developer of proprietary fiber-based bioactive glass products, announced today that it has received FDA 510(k) clearance of FIBERGRAFT™ BG Putty – Bone Graft Substitute. This is the second generation product in the company’s FIBERGRAFT™ line of bioactive glass based products. FIBERGRAFT™ BG Putty leverages the direct connectivity of fibers with an exponentially increased surface area and optimized resorption rates delivered using Prosidyan™’s proprietary bioactive carrier, OSSIGLIDE™.
FIBERGRAFT™ BG Putty – Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the 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 Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
Prosidyan™ was founded in 2009 to develop a family of synthetic bioactive bone graft substitutes based on microscopic fibers of bioactive glass. Prosidyan’s first product FIBERGRAFT™ BG Morsels was FDA cleared in March 2014 as a bone void filler. The product has been successfully used in over 800 surgeries to date. FIBERGRAFT™ BG Putty is FIBERGRAFT™ BG Morsels delivered through Prosidyan™’s proprietary bioactive carrier, OSSIGLIDE™.
Prosidyan™’s President and CEO, Charanpreet Bagga, elaborates on the importance of this latest product: “Bioactive glass is becoming increasingly prevalent in today’s marketplace. FIBERGRAFT™ BG Putty is highly differentiated due to the proprietary structure and our bioactive carrier, OSSIGLIDE™. The marriage of these technologies provides surgeons a bone graft based upon a technology with which they already have clinical experience, but has better handling.”
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.