Grafton™ DBF/Grafton™ DBF Inject
INDICATIONS FOR USE
Grafton™ DBF can be used in orthopedic or reconstructive bone grafting procedures. The product can also be used in bone grafting procedures in combination with autologous bone or other forms of allograft bone, or alone as a bone graft.
The presence of infection at the implantation site is a contraindication for the use of this allograft.
This allograft may contain trace amounts of antibiotics (gentamicin), antiseptic (povidone-iodine) and alcohol solutions. Caution should be exercised if the patient is allergic to these antibiotics or chemicals.
Syringe Accessory Kit
The Graft Preparation and Delivery Device is intended for the delivery of hydrated allograft, autograft or synthetic bone graft materials to an orthopaedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as I.V. fluids, blood, plasma concentrate, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.
There are no specific warnings, precautions, or adverse effects associated with the use of this device.
A minimally invasive pedicle screw system based on CD Horizon Solera Spinal System platform technology.
MAST™ MIDLF stands for Midline Lumbar Fusion.
NOTE: The Divergence-L Anterior/Oblique Lumbar Fusion System must be used with a supplemental fixation system cleared for use in the lumbar spine. Sovereign interbody spacers with lordosis angles less than 24° may be used as a stand-alone device or in conjunction with supplemental fixation. They can be used stand-alone with the three titanium alloy fixed or variable angle screws. If less than three of the provided screws are used, additional supplemental fixation in the lumbar spine must be used to augment stability. Interbody implants with 24° of lordosis angles are intended to be used with supplemental fixation (e.g., facet screws or posterior fixation).
FiberCel is a human tissue allograft consisting of cryopreserved cancellous and corticocancellous bone matrix that is aseptically processed to preserve native factors that support bone repair. FiberCel is a Human Cellular and Tissue Based Product (HCT/P) per 21 CFR Part 1271. Each allograft is restricted to homologous use for transplant in procedures for repair, replacement or reconstruction on a single occasion by a licensed physician or surgeon. FiberCel can be used in orthopedic or reconstructive bone grafting procedures in combination with autologous bone or other forms of allograft bone, or alone as a bone graft.
Contraindications: The presence of infection at the transplant site is a contraindication for the use of this allograft.
BRIEF SUMMARY OF INDICATIONS, CONTRAINDICATIONS, AND WARNINGS FOR:
Infuse Bone Graft/LT-Cage™ Lumbar Tapered Fusion Device
Infuse Bone Graft/Inter Fix™ Threaded Fusion Device
Infuse Bone Graft/Inter Fix™ RP Threaded Fusion Device
Infuse Bone Graft/Perimeter™ Interbody Fusion Device
Infuse Bone Graft/Clydesdale™ Spinal System
Infuse Bone Graft/Divergence-L™ Anterior/Oblique Lumbar Fusion System
Infuse Bone Graft/Pivox™ Oblique Lateral Spinal System
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 1 spondylolisthesis or Grade 1 retrolisthesis at the involved level.
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.
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).
There are no adequate and well-controlled studies in human pregnant women. In an experimental rabbit study, rhBMP-2 has been shown to elicit antibodies that are capable of crossing the placenta. Women of child bearing potential should be warned by their surgeon of potential risk to a fetus and informed of other possible orthopedic treatments. The safety and effectiveness of this device has not been established in nursing mothers. Women of child- bearing potential should be advised to not become pregnant for one year following treatment with this device.
Please see the Infuse Bone Graft package insert for the complete list of indications, warnings, precautions, adverse events, clinical results, definition of DDD, and other important medical information. The package insert also matches the sizes of those sized devices that are indicated for use with the appropriate Infuse Bone Graft kit. An electronic version of the package insert may be found at www.medtronic.com/manuals.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician with appropriate training or experience.
Comparisons were made utilizing control samples that were produced using a process similar to existing cellular bone matrices. Samples for the comparison were obtained from identical sources.
Certain sizes of the Divergence-L™ Anterior/Oblique Lumbar Fusion System and PEEK Perimeter™ Interbody Fusion Device interbody cages may also be used with Infuse™ Bone Graft in patients diagnosed with DDD. The device may be implanted at a single level using an Anterior Lumbar Interbody Fusion (ALIF) approach from L2-S1. The device may also be implanted at a single level using an Oblique Lateral Interbody Fusion (OLIF) approach from L5 to S1. Consult the labeling for the Infuse Bone Graft/Medtronic Interbody Fusion Device for information on the specific sizes of the Clydesdale™ Spinal System or Pivox ™ Oblique Lateral Spinal System approved for use with Infuse Bone Graft, as well as specific information regarding contraindications, warnings, and precautions associated with Infuse Bone Graft. Infuse Bone Graft is not indicated for use in a direct lateral interbody fusion (DLIF) surgical approach. Refer to the Infuse Bone Graft/Medtronic Interbody Fusion Device package insert for additional information.
Approved for use in certain spinal, dental, and trauma indications.
Data on file. Animal testing not necessarily indicative of human clinical outcomes.
Bruffey JD, Regan J, McMillan M, Ingram R, Bondre S. Update in Minimally Invasive Spine (MIS) Surgery: Clinical Examples of Anatomy, Indications, and Surgical Techniques. Tucson, AZ: Center For Advanced Spinal Surgery of Southern Arizona; June 13, 2011.
Santoni BG, Hynes RA, McGilvray KC, Rodriguez-Canessa G, Lyons AS, Henson MA, Womack WJ, Puttlitz CM. Cortical bone trajectory for lumbar pedicle screws. Spine J. 2009 May;9(5):366-373. Epub 2008 Sep 14.