Infuse™ Bone Graft / Medtronic Interbody Fusion Device

The Infuse™ Bone Graft / Medtronic Interbody Fusion Device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1, who may also have up to Grade I spondylolisthesis or Grade 1 retrolisthesis at the involved level.

Infuse™ Bone Graft / Medtronic Interbody Fusion Device (Credit: Medtronic)

Infuse™ Bone Graft / Medtronic Interbody Fusion Device (Credit: Medtronic)

The following interbody devices and surgical approaches may be used with Infuse™ Bone Graft:
  • The LT-Cage™ Lumbar Tapered Fusion Device, implanted via an anterior open or an anterior laparoscopic approach at a single level.
  • The Inter Fix™ or Inter Fix™ RP Threaded Fusion Device, implanted via an anterior open approach at a single level.
  • 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 Clydesdale™ 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 Pivox™ Oblique Lateral Spinal System implanted via an OLIF approach at a single-level from L2-L5.

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. These components must be used as a system for the prescribed indication described above. 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. The Infuse™ Bone Graft component must not be used without the Medtronic Interbody Fusion Device component.

Medtronic Titanium Threaded Interbody Fusion Device Components

LT-CAGE™ Lumbar Tapered Fusion Device

The LT-CAGE™ Device consists of a hollow, perforated, machined cylinder with opposing flat sides. There are two holes on each of the two flat sides. On each of the two rounded aspects, there is a single rounded slot. The implants have a helical screw thread on the outer surface. One end of the device is closed. The other end is open to be filled with the INFUSE™ Bone Graft component.

The LT-CAGE™ implants are made from implant-grade titanium alloy (Ti-6Al-4V) described by such standards as ASTM F136 or its ISO equivalent.

The LT-CAGE™ Lumbar Tapered Fusion Device component is sold separately from the INFUSE™ Bone Graft component; however, these two components must be used together. The package labeling for the LT-CAGE™ Lumbar Tapered Fusion Device contains complete product information for this component.

INTER FIX™ Threaded Fusion Device

The INTER FIX™ Device consists of a hollow, perforated cylinder with parallel sides and an endcap. The endcaps of the INTER FIX™ cages are sized according to the diameter of the cylinders and are applied to the open end of the cylinders after they are filled with INFUSE™ Bone Graft.

The INTER FIX™ Threaded Fusion Device implants are made from implant-grade titanium alloy (Ti-6Al-4V) described by such standards as ASTM F136 or its ISO equivalent.

The INTER FIX™ Threaded Fusion Device component is sold separately from the INFUSE™ Bone Graft component; however, these two components must be used together. The package labeling for the INTER FIX™ Threaded Fusion Device contains complete product information for this component.

INTER FIX™ RP Threaded Fusion Device

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

The INTER FIX™ RP Threaded Fusion Device component is sold separately from the INFUSE™ Bone Graft component; however, these two components must be used together. The package labeling for the INTER FIX™ RP Threaded Fusion Device contains complete product information for this component.

PERIMETER™ Interbody Fusion Device

The PERIMETER™ Interbody Fusion Device consists of PEEK cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with INFUSE™ Bone Graft.

The PERIMETER™ Interbody Fusion Device is offered in a variety of sizes, although only certain sizes of the PEEK device are approved for use with INFUSE™ Bone Graft. The device is designed with teeth across both the superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus providing expulsion resistance. The PERIMETER™ Interbody Fusion Device component is sold separately from the INFUSE™ Bone Graft component; however, these two components must be used together. The package labeling for the PERIMETER™ Interbody Fusion Device contains complete product information for this component.

CLYDESDALE™ Spinal System

The CLYDESDALE™ Spinal System consists of PEEK cages of various widths and heights, which include tantalum markers. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with INFUSE™ Bone Graft. The CLYDESDALE™ Spinal System component is sold separately from the INFUSE™ Bone Graft component; however, these two components must be used together. The package labeling for the CLYDESDALE™ Spinal System contains complete product information for this component.

DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System

The DIVERGENCE-L™Anterior/Oblique Lumbar interbody cages, which are available in various widths, heights, and lordosis, can be inserted between two lumbar vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with INFUSE™ Bone Graft and must be used with supplemental fixation. The cages are manufactured from medical grade PEEK and titanium alloy with tantalum markers and are provided sterile.

PIVOX™ Oblique Lateral Spinal System

The PIVOX™ Oblique Lateral Spinal System interbody cages are available in various widths, heights, and lordosis, and can be inserted between two lumbar vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with INFUSE™ Bone Graft and must be used with supplemental fixation. The cages are manufactured from medical grade PEEK and titanium alloy with tantalum markers and are provided sterile.

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 LT-CAGE™ Lumbar Tapered Fusion Device, the PERIMETER™ Interbody Fusion Device, the CLYDESDALE™ Spinal System, the DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System, and the PIVOX™ Oblique Lateral Spinal System implants are not to be used in conjunction with either the INTER FIX™ or INTER FIX™ RP implants to treat a spinal level.

The PERIMETER™, CLYDESDALE™, DIVERGENCE-L™, and PIVOX™ devices must be used with any supplemental fixation system cleared for use in the lumbar spine.


INFUSE™ Bone Graft Component

INFUSE™ Bone Graft consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2, known as dibotermin alfa) placed on an absorbable collagen sponge (ACS). The INFUSE™ Bone Graft component induces new bone tissue at the site of implantation. Based on data from non-clinical studies, the bone formation process develops from the outside of the implant towards the center until the entire INFUSE™ Bone Graft component is replaced by trabecular bone.

rhBMP-2 is the active agent in the INFUSE™ Bone Graft component. rhBMP-2 is a disulfide-linked dimeric protein molecule with two major subunit species of 114 and 131 amino acids. Each subunit is glycosylated at one site with high-mannose-type glycans. rhBMP-2 is produced by a genetically engineered Chinese hamster ovary cell line.

rhBMP-2 and excipients are lyophilized. Upon reconstitution, each milliliter of rhBMP-2 solution contains: 1.5mg of rhBMP-2; 5.0mg sucrose, NF; 25mg glycine, USP; 3.7mg L-glutamic acid, FCC; 0.1mg sodium chloride, USP; 0.1mg polysorbate 80, NF; and 1.0mL of sterile water. The reconstituted rhBMP-2 solution has a pH of 4.5; is clear, colorless to slightly yellow; and is essentially free from plainly visible particulate matter. The concentration of rhBMP-2 is 1.5mg/ml. The ACS is a soft, white, pliable, absorbent implantable matrix for rhBMP-2. ACS is made from bovine Type I collagen obtained from the deep flexor (Achilles) tendon. The ACS acts as a carrier for the rhBMP-2 and acts as a scaffold for new bone formation.

The INFUSE™ Bone Graft component is prepared at the time of surgery and allowed a prescribed amount of time (no less than 15 minutes) before placement inside of the Medtronic Interbody Fusion Device components. The Instructions for Preparation contain complete details on preparation of the INFUSE™ Bone Graft / Medtronic Interbody Fusion Device. Various sizes of INFUSE™ Bone Graft kits are available based on the internal volume of the Medtronic Interbody Fusion Device component that is selected. Each kit contains all the components necessary to prepare the INFUSE™ Bone Graft component: the rhBMP-2, which must be reconstituted; sterile water; absorbable collagen sponge(s); syringes with needles; this package insert; and instructions for preparation.

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 LT-Cage™ Lumbar Tapered Fusion Device, the Perimeter™ Interbody Fusion Device, the Clydesdale™ Spinal System, the Divergence-L™ Anterior/Oblique Lumbar Fusion System, and the Pivox™ Oblique Lateral Spinal System implants are not to be used in conjunction with either the Inter Fix™ OR Inter Fix™ RP implants to treat a spinal level.

The Infuse™ Bone Graft / Medtronic Interbody Fusion Device is contraindicated for patients with a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen, or to other components of the formulation and should not be used in the vicinity of a resected or extant tumor, in patients with any active malignancy, or patients undergoing treatment for a malignancy; in patients who are skeletally immature; in pregnant women; or in patients with an active infection at the operative site or with an allergy to titanium, titanium alloy, or polyetheretherketone (PEEK).


This product incorporates technology developed by Gary K. Michelson, M.D.

This product incorporates technology developed by Gary K. Michelson, M.D.