ACCESS and DISC PREP INSTRUMENTS

OLIF25 RETRACTOR SYSTEM

Medtronic spine OLIF25 retractor system with single-step dilation & flex arms that allow retraction with T-handle.
  • Round blade option accommodates traditional sequential, tubular dilation.
  • Flat blade option supports single-step dilation and is optimized for the OLIF25 approach.
  • Flex arm allows retraction fine-tuning with T-handle.

DISC PREP SET

Medtronic spine disc prep set with anterolateral approaches & Navigated Anterolateral disc prep for SynergyOLIF25 procedure.
  • Instrumentation tailored to anterolateral approaches.
  • Navigated Anterolateral Disc Prep Instruments available for SynergyOLIF25SM procedure.

INTERBODY SYSTEMS

PIVOX™ OBLIQUE LATERAL SPINAL SYSTEM

Medtronic spine PIVOX oblique lateral spinal system with oblique/direct lateral placement for Infuse Bone Graft, used in the OLIF25 and DLIF procedures.
  • Variable angled insertion swivels from 0°-40° to enable either oblique or direct lateral placement.
  • 6°, 12°, or 18° lordosis.
  • 20 mm width.
  • Two-hole plate cleared for supplemental fixation, inserted simultaneously with the cage, or independently via the oblique or direct 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 OLIF25 Procedures or DLIF Procedures.

CLYDESDALE™ SPINAL SYSTEM

Medtronic spine Clydesdale spinal system with surgical navigation solutions & Infuse Bone Graft used for OLIF25 and DLIF procedures.
  • Compatible with Medtronic surgical navigation solutions.
  • 6° or 12° lordosis.
  • 18 or 22 mm widths.
  • Convex shape with angular teeth.
  • 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 OLIF25 Procedures or DLIF Procedures.

CLYDESDALE™ PTC SPINAL SYSTEM

Medtronic spine Clydesdale PTC Spinal System with titanium coating (PTC), PEEK interbody fusion device.
  • Commercially Pure Titanium Coating (PTC) plasma-sprayed onto endplates of Clydesdale PEEK Interbody Fusion Device via proprietary method.
  • Facilitates a roughened surface and increased surface area.2
  • 6° or 12° lordosis.
  • 18 or 22 mm widths.
  • Convex shape with angular teeth.

Endoskeleton™ TL Interbody System

Medtronic spine Titan Endoskeleton TL with nanoLOCK/Endoskeleton surfaces & radiopaque interbody with endplate-sparing for bone grafting.
  • Available with proprietary Titan nanoLOCK™ Surface Technology or Endoskeleton™ surface features.
  • Radiopaque interbody with endplate-sparing design and large windows for bone grafting.
  • Available in 18 or 22 mm width and 45, 50, 55, or 60 mm length.

BIOLOGICS

INFUSE™ BONE GRAFT

Medtronic spine infuse bone graft with autograft replacement for Pivox and Clydesdale devices in OLIF25 procedures.
  • Premium product for autograft replacement due to its high osteoinductivity.3
  • Available for use with certain sizes of Pivox and Clydesdale devices in OLIF25 procedures in patients with DDD from L2-L5 at a single level.1

Learn more about Infuse Bone Graft

Fibercel™ Viable Bone Matrix (VBM)

Medtronic spine OLIF25 Fibercel VBM with human tissue allograft consisting of cryopreserved cancellous and conrticocancellous bone matrix.
  • Human tissue allograft consisting of cryopreserved cancellous and corticocancellous bone matrix that is aseptically processed to preserve native factors that support bone repair.
  • Healthier cells.*4
  • Fiber technology.
  • Improved handling.

 

GRAFTON™ DBF

Medtronic spine Grafton DBM DBF for OLIF25 procedure for use in the thoracolumbar spine only.
  • High osteoinductivity.4
  • 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.5
  • Surgical access respects the muscular and neurovascular elements.5
  • Divergent screw trajectory away from neural elements.6

NAVIGATION AND IMAGING

O-ARM™ IMAGING SYSTEM AND STEALTHSTATION™ S8 SURGICAL NAVIGATION SYSTEM

Certain implant systems can be navigated during an OLIF25 Procedure with the O-arm Imaging System and StealthStation S8 Surgical Navigation System.

The end result is a fully integrated procedural solution using enabling technologies.

Learn More About Navigation

Medtronic spine OLIF25 O-ARM Imaging System and Stealthstation S8 Surgical Navigation System.

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Learn more about OLIF procedures.

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Male physician and single-position surgery specialist

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FIBERCEL™ VBM DESCRIPTION AND INTENDED USE

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.

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

Refer to the Infuse™ Bone Graft/Medtronic Interbody Fusion Device package insert for additional information.

2

Medtronic Internal Data: 3D laser scanning microscope measurements.

3

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

4

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

5

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.

6

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.