#INFUSE BONE GRAFT ISO#

Towards the center until the entire INFUSE™ Bone Graft component is replaced by trabecular bone. Based on data from non-clinical studies, the bone formation process develops from the outside of the implant The INFUSE™ Bone Graft component induces new bone tissue at the site of Placed on an absorbable collagen sponge (ACS). INFUSE™ Bone Graft consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2, known as dibotermin alfa) The PERIMETER™, CLYDESDALE™, DIVERGENCE-L™, and PIVOX™ devices must be used with any supplemental fixation system cleared for use in the lumbar spine. INTER FIX™ RP implants to treat a spinal level. PIVOX™ Oblique Lateral Spinal System implants are not to be used in conjunction with either the INTER FIX™ or The LT-CAGE™ Lumbar Tapered Fusion Device, the PERIMETER™ Interbody Fusionĭevice, the CLYDESDALE™ Spinal System, the DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System, and the NOTE: The INTER FIX™ Threaded Fusion Device and the INTER FIX™ RP Threaded Fusion Device may be used together to treat a spinal level. The cages are manufactured from medical grade PEEK and titanium alloy with tantalum markers and are provided Hollow geometry of the implants allows them to be packed with INFUSE™ Bone Graft and must be used with supplementalįixation. Inserted between two lumbar vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The PIVOX™ Oblique Lateral Spinal System interbody cages are available in various widths, heights, and lordosis, and can be The package labeling for the INTER FIX™ RP Threaded Fusionĭevice contains complete product information for this component. However, these two components must be used together. The INTER FIX™ RP Threaded Fusion Device component is sold separately from the INFUSE™ Bone Graft component

#INFUSE BONE GRAFT ISO#

Such standards as ASTM F136 or its ISO equivalent. The INTER FIX™ RP Threaded Fusion Device implants are made from implant-grade titanium alloy (Ti-6Al-4V) described by Both ends of the INTER FIX™ RP implant are closed. The INTER FIX™ RP Device consists of a hollow, perforated cylinder with a single, large, outer-radiused groove along theĮntire longitudinal axis that extends into the inside diameter of the device. The package labeling for the INTER FIX™ Threaded Fusion Device containsĬomplete product information for this component.

These two components must be used together. The INTER FIX™ Threaded Fusion Device component is sold separately from the INFUSE™ Bone Graft component however, Standards as ASTM F136 or its ISO equivalent. The INTER FIX™ Threaded Fusion Device implants are made from implant-grade titanium alloy (Ti-6Al-4V) described by such The endcaps of the INTERįIX™ cages are sized according to the diameter of the cylinders and are applied to the open end of the cylinders after they are The INTER FIX™ Device consists of a hollow, perforated cylinder with parallel sides and an endcap.

Medtronic Titanium Threaded Interbody Fusion Device Components The Infuse™ Bone Graft component must not be used without the Medtronic Interbody Fusion Device component. The bone morphogenetic protein solution component must not be used without the carrier/scaffold component or with a carrier/scaffold component different from the one described in this document. These components must be used as a system for the prescribed indication described above. The Infuse™ Bone Graft / Medtronic Interbody Fusion Device consists of two components containing three parts – a spinal fusion cage, a recombinant human bone morphogenetic protein, and a carrier/scaffold for the bone morphogenetic protein and resulting bone. The Pivox™ Oblique Lateral Spinal System implanted via an OLIF approach at a single-level from L2-L5.The Divergence-L™ Anterior/Oblique Lumbar Fusion System interbody device implanted via an ALIF approach at a single level from L2-S1 or an OLIF approach at a single level from L5-S1.The Clydesdale™ Spinal System, implanted via an OLIF approach at a single level from L2-L5.The Perimeter™ Interbody Fusion Device implanted via a retroperitoneal anterior lumbar interbody fusion (ALIF) at a single level from L2-S1 or an oblique lateral interbody fusion (OLIF) approach at a single level from L5-S1.The Inter Fix™ or Inter Fix™ RP Threaded Fusion Device, implanted via an anterior open approach at a single level.The LT-Cage™ Lumbar Tapered Fusion Device, implanted via an anterior open or an anterior laparoscopic approach at a single level.The following interbody devices and surgical approaches may be used with Infuse™ Bone Graft:

Infuse bone graft