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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® Aeridyan™ Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® Aeridyan™ Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, 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® Aeridyan™ Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine. FIBERGRAFT® Aeridyan™ Matrix must be hydrated with saline or blood for pelvis and extremity applications.

FIBERGRAFT® Aeridyan™ Matrix product is composed of 4585 bioactive glass (M-45 granules), boron bioactive glass (MS-B microspheres/Borospheres™) and bovine type I collagen. After hydration with saline, blood or bone marrow aspirate (BMA), the Aeridyan™ Matrix can be applied directly to the defect site or molded into the desired shape and gently packed into the defect site as a non-setting putty. In posterolateral spine fusion applications, the product is intended to be hydrated with bone marrow aspirate (BMA) and mixed with autograft in a recommended 1:1 ratio. In pelvis and extremity applications, the product must be hydrated with saline or blood.

FIBERGRAFT® AERIDYAN Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® AERIDYAN Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine). 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® AERIDYAN Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.

FIBERGRAFT® AERIDYAN Matrix product is composed of 45S5 bioactive glass (M-45 granules), boron bioactive glass (MS-B microspheres) and bovine type I collagen. After hydration with bone marrow aspirate (BMA), the AERIDYAN Matrix can be applied directly to the defect site or molded into the desired shape and gently packed into the defect site as a nonsetting putty. In the posterolateral spine fusion applications, the product is intended to be hydrated with BMA and mixed with autograft in a 1:1 ratio.

FIBERGRAFT® BG Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® BG Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, 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 Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.

FIBERGRAFT® BG Matrix product is composed of 45S5 bioactive glass components (M-45 granules, MS-45 microspheres) and bovine type I collagen. The BG Matrix after hydration with saline or blood can be applied to the defect site or can be molded into the desired shape and gently packed into the defect site as a non-setting putty. In the posterolateral spine fusion applications, the product is intended to be hydrated with bone marrow aspirate (BMA) and mixed with autograft in a 1:1 ratio. The FIBERGRAFT® BG Matrix product was previously cleared in K171284. There has not been any change to the device since the last clearance.

FIBERGRAFT® BG Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® BG Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine). 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 Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.

FIBERGRAFT® BG Matrix product is composed of 45S5 bioactive glass components (M-45 granules, MS-45 microspheres) and bovine type I collagen. The product is intended to be hydrated with BMA and mixed with autograft in a 1:1 ratio.

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., posterolateral spine, 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 must be used with autograft in the posterolateral spine. 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 an osteoconductive, resorbable, biocompatible bone graft substitute to be gently packed into defect sites and to be used as non-structural scaffolds. The FIBERGRATT® BG putty is made from 45S5 bioactive glass, where the bioactive glass components are mixed with an absorbable binder to form a cohesive material.

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.

FIBERGRAFT™ BG Morsels Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Morsels 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 the healing process. FIBERGRAFT™ BG Morsels is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

FIBERGRAFT™ BG Morsels provides an osteoconductive, resorbable, biocompatible bone graft substitute made from crystalline 45S5 bioactive glass. Each granule of FIBERGRAFT™ BG Morsels is created from a matrix of bioactive glass fibers and microspheres. Bioactive glass is defined as a group of glasses which has a compositional range that allows the formation of hydroxyapatite (HA) as a surface layer when exposed to an aqueous phosphate-containing solution such as simulated body fluid. The HA layer that forms in an aqueous phosphate-containing solution plays a significant role in forming a strong bond with natural bone. The granules provide an ultra-porous scaffold for desired biological response and improved handling characteristics, while optimizing radiopacity and resorption. FIBERGRAFT™ BG Morsels are generally spherical in appearance and provided in granular form. The matrix is flash sintered to form a porous shell at its surface, which creates the generally spherical structure of the granules, while maintaining a level of porosity within each granule. The primary purpose of this submission is to add the option to use blood to mix with the product prior to implantation. Changes were also made to the product trade name and the labeled volume sizes.

BG Morsels - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BG Morsels 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. BG Morsels is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

BG Morsels provides an osteoconductive, resorbable, biocompatible bone graft substitute made from crystalline 45S5 bioactive glass. Each granule of BG Morsels is created from a matrix of bioactive glass fibers and microspheres. Bioactive glass is defined as a group of glasses which has a compositional range that allows the formation of hydroxyapatite (HA) as a surface laver when exposed to an aqueous phosphate-containing solution such as simulated body fluid. The HA layer that forms in an aqueous phosphate-containing solution plays a significant role in forming a strong bond with natural bone. The granules provide an ultra-porous scaffold for desired biological response and improved handling characteristics, while optimizing radiopacity and resorption. BG Morsels are generally spherical in appearance and provided in granular form. The matrix is flash sintered to form a porous shell at its surface, which creates the generally spherical structure of the granules, while maintaining a level of porosity within each granule.