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GPS Advanced and GPS Advanced Cannula are intended for use to deliver FIBERGRAFT™ BG Putty GPS to a bone grafting site.

GPS Advanced is a sterile, single use dispenser for the delivery of FIBERGRAFT™ BG Putty GPS bone graft substitute. The dispenser has a ratcheted plunger that advances with each squeeze of its handle. The 5 cc GPS Advanced Cannula ("GPS Advanced Cannula") is available individually packaged and can be attached to the dispenser. GPS Advanced is provided sterile via irradiation and GPS Advanced Cannula is provided sterile via ethylene oxide. The GPS Advanced Cannula is provided empty and needs to be filled with FIBERGRAFT™ BG Putty GPS prior to use. FIBERGRAFT™ BG Putty GPS is a bioactive synthetic bone graft substitute in putty format made from 45S5 bioactive glass and has been previously cleared under K170306 (FIBERGRAFT™ BG Putty – Bone Graft Substitute) and K222276 (CONDUIT™ Cages and FIBERGRAFT™ BG Putty). FIBERGRAFT™ BG Putty GPS is not included in the GPS Advanced dispensing system.

GPS Advanced and GPS Advanced Cannula are intended for use to deliver FIBERGRAFT™ BG Putty GPS to a bone grafting site.

GPS Advanced is a sterile, single use dispensing system for the delivery of FIBERGRAFT™ BG Putty GPS bone graft substitute. The instrument system includes 1) a dispenser with a ratcheted plunger that advances with each squeeze of its handle and 2) two 5 cc GPS Advanced Cannulas which can be attached to the dispenser to deliver FIBERGRAFT™ BG Putty GPS. The 5 cc GPS Advanced Cannula (hereafter referred to as "GPS Advanced Cannula") is also available individually packaged. GPS Advanced and GPS Advanced Cannula are provided sterile via irradiation. GPS Advanced Cannulas are provided empty and need to be filled with FIBERGRAFT™ BG Putty GPS prior to use. FIBERGRAFT™ BG Putty GPS is a bioactive synthetic bone graft substitute in putty format made from 45S5 bioactive glass and has been previously cleared under K170306 (FIBERGRAFT™ BG Putty – Bone Graft Substitute) and K222276 (CONDUIT™ Cages and FIBERGRAFT™ BG Putty). FIBERGRAFT™ BG Putty GPS is not included in the GPS Advanced dispensing system.

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.

The FIBERGRAFT™ BG Putty is a osteoconductive, resorbable, biocompatible bone graff substitute to be gently packed into defect sites and to be used as non-structural scaffolds. The FIBERGRAFT™ BG putty is made from 45S5 bioactive glass, where the bioactive glass components are mixed with an absorbable binder to form a cohesive material.