For Immediate Release, June 23, 2017: PaxMed International, LLC announces, on behalf of Orthorebirth Co., Ltd. of Yokohama, Japan, the 510(k) clearance of ReBOSSIS85, synthetic, resorbable bone void filler. It is a composite material consisting of (by weight) 40% beta-tricalcium phosphate (β-TCP), 30% siloxane-containing vaterite (a form of calcium carbonate, CaCO3), and 30% poly(L-lactide-co-glycolide). The electrospinning process used in manufacturing ReBOSSIS85 results in a cotton-like (or glass wool-like) physical form. Due to its physical form, ReBOSSIS85 is flexible and can easily fill defects in appropriate amounts. ReBOSSIS85 is provided sterile for single-patient, single-use.
ReBOSSIS85 marks the 194th 510(k) clearance for PaxMed and the 45th clearance for Dr. Kevin Thomas, PaxMed’s Vice President and Director of Regulatory Affairs.