ACCESS & DISC PREP INSTRUMENTS

OLIF51 TRIPLE ARM SYSTEM

Medtronic spine OLIF51 Triple Arm System with three radiolucuent blades.
  • Rigid, table-mounted, triple arm frame retractor with three radiolucent blades.
  • Blade channel includes disposable light source and integrated suction.

DISC PREP SET

Medtronic spine disc prep set with anterolateral approaches & Navigated Anterolateral disc prep for SynergyOLIF25 procedure.
  • Disc preparation instrumentation tailored to anterolateral approaches.
  • Instruments are optimized for procedure including Double-sided Cobb and Angled Pituitaries.
  • Straight and angled instrumentation accommodate for OLIF51 and ALIF Procedures.
  • Navigated Disc Prep instruments are also available.

INTERBODY SYSTEMS

DIVERGENCE-L™ ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM

Medtronic spine Divergence-L Anterior/Oblique Lumbar Fusion System with an L5/S1 implant available for OLIF51 and ALIF procedures.
  • L5/S1 implant available for the OLIF51 and ALIF Procedures.
  • Available in small, medium, and large footprints, with hyperlordotic options up to 24°.
  • Anterior plate with diverging screws may be inserted via an anterior or lateral approach.
  • Certain sizes are approved with Infuse™ Bone Graft in patients with DDD from L2-L5 at a single-level.1
  • Can be used in the OLIF51 or ALIF Procedures.

SOVEREIGN™ SPINAL SYSTEM

Medtronic Sovereign Spinal interbody system with intrinsic screw fixation used in OLIF and ALIF procedures, allows for hyperlordotic options.
  • Interbody system with intrinsic screw fixation used in OLIF51 or ALIF Procedures.
  • Available in small, medium, and large footprints, with hyperlordotic options up to 24°.
  • Three intrinsic screws threaded through the interbody cage.

ENDOSKELETON™ TA INTERBODY SYSTEM

Titan endoskeleton TA used in the ALIF and OLIF51 approaches, designed for smooth and accurate placement.

Learn more about Titan Endoskeleton TA

ENDOSKELETON™ TAS/TASH INTERBODY SYSTEM

Medtronic spine OLIF51 product Titan Endoskeleton TAS/TASH with nanoLOCK or Endoskeleton surface features and endplate-sparing design for bone grafting.
  • Available with proprietary Titan nanoLOCK™ Surface Technology or Endoskeleton™ surface features.
  • Radiopaque interbody with integrated fixation.
  • Endplate-sparing design and large windows for bone grafting.
  • TAS is available in 7° or 12° of lordosis, TASh is available in 16°, 20°, or 24° of lordosis.

Learn more about Titan Endoskeleton TAS/TASH

BIOLOGICS

INFUSE™ BONE GRAFT

Closeup of Divergence L with the Infuse bone graft.
  • Premium product for autograft replacement due to its high osteoinductivity.2
  • Available for use with certain sizes of Divergence devices in OLIF51 or ALIF procedures in patients with DDD from L2-L5 at a single level.1

Learn more about Infuse Bone Graft

GRAFTON™ DBF

Medtronic spine Grafton DBM DBF for OLIF25 procedure for use in the thoracolumbar spine only.
  • High osteoinductivity.3
  • Osteoconductive fibers.
  • Moldable.

Learn more about GRAFTON DBF

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.

CONTRAINDICATIONS
The presence of infection at the implantation site is a contraindication for the use of this allograft.

CAUTION
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

INTENDED USE
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.

WARNINGS/PRECAUTIONS
There are no specific warnings, precautions, or adverse effects associated with the use of this device.

POSTERIOR FIXATION

CD HORIZON™ SOLERA™ VOYAGER™ SYSTEM

Medtronic spine OLIF25 and OLIF51 CD Horizon Solera Voyager system, a minimally invasive pedicle screw system.

A minimally invasive pedicle screw system based on CD Horizon Solera Spinal System platform technology.

  • Available in 4.75 mm and 5.5 mm rod sizes.
  • High-strength, low-profile multi-axial screws.
  • Osteogrip™ dual-lead threadform.
  • Compatible with Navigation and Power.

CD HORIZON™ SOLERA™ SPINAL SYSTEM

Medtronic CD Horizon Solera Spinal System, Minimally invasive approach through a laminectomy incision for OLIF25 and OLIF51, MAST MIDLF stands for Midline Lumbar Fusion.

MAST™ MIDLF stands for Midline Lumbar Fusion.

  • Minimally invasive approach through a laminectomy incision.4
  • Surgical access respects the muscular and neurovascular elements.4
  • Divergent screw trajectory away from neural elements.5

CONTINUE THE   CONVERSATION

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VIEW EVENTS

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).

INFUSE™ BONE GRAFT BRIEF SUMMARY

SPINAL INDICATIONS

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.

1

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.

2

Approved for use in certain spinal, dental, and trauma indications.

3

Data on file. Animal testing not necessarily indicative of human clinical outcomes.

4

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.

5

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.