December 15, 2017: PaxMed International announces that it closed out a productive 2017 with the FDA 510(k) clearance of K172573 for ReBOSSIS85 resorbable bone void filler, on behalf of Orthorebirth Co., Ltd. of Yokohama, Japan. This submission expands the cleared indications for use of REBOSSIS85 to the posterolateral spine as a bone graft extender. The subject device is identical in material composition and physical form to the material cleared in K170620 for use in the pelvis and extremities.
ReBOSSIS85 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 and is marketed in the USA by ORTHOReBIRTH USA, of Georgetown, Texas.