The World's First ! ReBOSSIS ® Cotton-like Bioresorbable Bone Void Filler Handling Ability Bioresorbability Water Absorbability Osteogenic Ability ORTHOREBIRTH,Co.,Ltd. Description ReBOSSIS ReBOSSIS is a cotton-like resorbable bone void filler for the repair of bone defects, and consists of betatricalcium phosphate (β-TCP), silicon-doped vaterite ® Cotton-like Bioresorbable Bone Void Filler (a form of calcium carbonate), and a resorbable scaffold of poly-L-lactide (PLLa). ReBOSSIS contains 1% silicon by weight, a level similar to that present in normal growing bone. The diameter of the fibers in the PLLa scaffold ranges from 10 μm to 50 μm. The interconnected macro- and microporous structure allows for formation of new bone and the growth of capillary blood vessels throughout the network of interconnecting pores. Animal Studies Indications for Use ReBOSSIS is a bone void filler intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. ReBOSSIS is indicated to be packed gently into ・Rabbit study - distal femur bony voids or gaps of the skeletal system ・Defecdts(6-mm in diameter and 10-mm deep) were (extremities and pelvis), and may be used without created in the cancellous bone. hydration or hydrated with bone marrow aspirate ・The materials were hydrated with BMA in a 1:1 by or blood. The device provides a bone void filler that volume. is resorbed and replaced with host bone during the ・New bone formation is observed at 12 weeks. healing process. How Supplied ReBOSSIS is provided in the following amounts: Products ● No.ORB-0107B volume : 0.7g (18cc) ● No.ORB-0110B volume : 1.0g (25cc) ● No.ORB-0120B volume : 2.0g (50cc) 50 cc (2.0 g), 25 cc (1.0 g), and 18 cc (0.7 g). ReBOSSIS may be used without hydration or hydrated with autologous bone marrow aspirate or blood. The volume of ReBOSSIS is reduced from dry to hydrated as follows (approximately): from 50 cc to 20 cc, from 25 cc to 10 cc, and from 18 cc to 7 cc. The volume of ReBOSSIS 50cc (2.0g) 25cc (1.0g) 18cc (0.7g) After hydration 20cc 10cc 7cc ReBOSSIS ® Composition of ReBOSSIS β-tricalcium phosphate (β-TCP) Siloxane-containing calcium carbonate Poly-L-lactide (PLLa) Made in Japan, Manufactured by ORTHOREBIRTH Co., Ltd. 3-17-43 Chigasaki-Higashi, Tsuzuki-ku, Yokohama-shi, Kanagawa 224-0033, Japan E-Mail : [email protected] URL : http://www.orthorebirth.com