MAZOR™ ROBOTIC GUIDANCE PLATFORM

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The content below provides an informational overview of the Mazor™ instrumentation and workflows currently under development and is only intended to reflect the development strategy and future of technology. ​These products are not currently available or approved. 

Midas Rex™ Attachments and Dissecting Tools for Mazor™ system are pending FDA 510(k) clearance and are not available for sale. 

The software that supports the use of Mazor X Stealth Edition™ system with the following products, is pending FDA 510(k) clearance and is not available for sale.

Stealth-Midas™ High Speed Drill
Medtronic Navigated Disc Preparation Tools
Navigated Elevate™ Interbody Inserter
Medtronic Navigated Inserter

Mazor™ Platform Medical Education Opportunities

Innovation Coming to your O.R. Soon

Closeup image of a healthcare professional using the Midas Rex Mazor during medical procedure

DRILLING

Midas Rex™ Mazor attachments and tools

Closeup image of medical professional using the Access Stealth Midas Navigated Drill

ACCESS

Stealth-Midas™ Navigated High Speed Drill (available with Scan and Plan workflow only).

Image of a navigated cage insertion procedure

NAVIGATED INTERBODY ACCESS

Navigated disc prep and trialing(navigated osteotomes available with Scan and Plan workflow only).Navigated disc prep and trialing

Image of a navigated cage insertion procedure

NAVIGATED INTERBODY INSERTION WITH BIOLOGICS

Elevate™, Capstone™, Clydesdale™ Systems

Mazor™ Robotic Guidance Platform: The innovation Continues - 10:21

AVAILABLE NOW

Mazor X Stealth Edition™ system OLIF360^(SM) Single-position workflow - 10:58

Mazor X Stealth Edition™ system TLIF workflow - 40:32

CLINICAL EVIDENCE BROCHURES

pdf Clinical Value Highlight of Mazor™ Core Technology (.pdf)

Clinical value highlights, based on a decade experience with Mazor Core Technology

657KB

OLIF360SM SINGLE-POSITION WITH MAZORTM PLATFORM

FOR MORE INFORMATION ON MAZOR™ ROBOTIC GUIDANCE PLATFORM VISIT:

Important Safety Infromation and Warnings

MAZOR X STEALTH EDITION™ ROBOTIC GUIDANCE PLATFORM​

INDICATIONS​

The Mazor X™ is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery. It may be used in either open or minimally invasive or percutaneous procedures.​

Mazor X™ 3-D imaging capabilities provide a processing and conversion of 2-D fluoroscopic projections from standard C-Arms into volumetric 3-D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3-D imaging of high contrast objects. ​

The Mazor X™ navigation tracks the position of instruments, during spinal surgery, in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient.

IMPORTANT INFORMATION ON THE MEDTRONIC SURGICAL INSTRUMENTS

FOR USE WITH MAZOR X STEALTH EDITION™ MAZOR™ ROBOTIC GUIDANCE PLATFORM

DESCRIPTION
Medtronic Surgical Instruments are non-sterile or sterile, single or re-usable instruments that may be used during the preparation and placement of various Medtronic spinal implants during spinal surgery. Medtronic Surgical Instruments are made of a variety of materials commonly used in orthopedic and neurological procedures which meet available national or international standards specifications. Single-use Medtronic Surgical instruments should never be reused under any circumstances.​

The Medtronic Surgical Instruments are specifically designed for use in spinal procedures with MAZOR X Stealth™ Edition. Medtronic Surgical Instruments can be navigated or non-navigated manual instruments that may or may not be guided through the MAZOR X Stealth™ Edition Arm Guide. Some Medtronic Surgical Instruments (e.g. drills, drivers, taps etc.) are also compatible with Medtronic’s IPC™ POWEREASE™ System when connected to the POWEREASE™ Driver, these Medtronic Surgical instruments may or may not be guided through the MAZOR X Stealth™ Edition Arm Guide.​

Medtronic surgical drills shall only be used through the MAZOR X Stealth™ Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Placing Medtronic single-use sterile spheres on each of the NavLock™ Tracker passive stems allow MAZOR X Stealth™ Edition to track the Medtronic Surgical Instruments in the surgical field.​

INTENDED USE
Medtronic Surgical Instruments are intended to be used during the preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the MAZOR X Stealth™ Edition, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Surgical Instruments can be navigated or non-navigated manual instruments that may or may not be guided through the MAZOR X Stealth™ Edition Arm Guide. Medtronic surgical drills shall only be used through the MAZOR X Stealth™ Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ POWEREASE™ System.​

IMPORTANT INFORMATION ON THE MEDTRONIC SURGICAL INSTRUMENTS FOR USE WITH THE IPC™ POWEREASE™ SYSTEM

IPC™ System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.​

The IPC™ POWEREASE™ System is indicated for drilling, tapping and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods.​

Do not implant the instruments.​

If there is any doubt or uncertainty concerning the proper use of these instruments, contact Medtronic. Any available surgical techniques will be provided at no charge.

PC™ System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.​

The IPC™ POWEREASE™ System is indicated for drilling, tapping and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods.​

Do not implant the instruments.​

If there is any doubt or uncertainty concerning the proper use of these instruments, contact Medtronic. Any available surgical techniques will be provided at no charge.

CD HORIZON™ SPINAL SYSTEM ​

INDICATIONS​

The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.​

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion.​

With the exception of DDD, the CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.​

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.​

The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This​ device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.​

The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor.​

In order to achieve additional levels of fixation, the CD Horizon™ Spinal System rods may be connected to the Vertex™ Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of the Vertex™ indications of use.​

POTENTIAL ADVERSE EVENTS

All of the possible adverse events associated with spinal fusion surgery without instrumentation are possible. With instrumentation, a listing of potential adverse events includes:​

  • Early or late loosening of any or all of the components.​
  • Disassembly, bending, or breakage of any or all of the components.​
  • Tissue or nerve damage caused by improper positioning and placement of implants ​
    or instruments.​

Note: additional surgery may be necessary to correct some of these potential ​
adverse events.

ELEVATE™ SPINAL SYSTEM​

INDICATIONS​

The Elevate™ Spinal System Expandable Interbody Fusion Device is indicated for interbody fusion with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone in  patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis   r retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic  studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted  via an open or a minimally invasive posterior approach. These implants are to be used with autogenous and/or allogenic bone graft comprised  of cancellous and/or corticocancellous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. These devices  are intended to be used with supplemental fixation instrumentation, which  has been cleared by the FDA for use in the lumbar spine. 

RISKS ​

Adverse effects may occur when the device is used either with or without associated instrumentation. The risk of adverse effects as a result of movement and non-stabilization may increase in cases where associated complementary support is not employed. Potential adverse events include, but are not limited to: ​

  • Implant migration.​
  • Breakage of the device(s).​
  • Pressure on the surrounding tissues or organs.​
  • Loss of proper spinal curvature, correction, height, and/or reduction.​

GRAFTON™ DBF/GRAFTON™ DBF INJECT Demineralized Bone Matrix ​

INDICATIONS​

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. ​

CLYDESDALE™ SPINAL SYSTEM​

INDICATIONS​

The Clydesdale™ Spinal System is intended to be used in interbody fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the Clydesdale™ Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine.​

Certain sizes of the Clydesdale™ Spinal System may be used with Infuse™ Bone Graft in single-level Oblique Lateral Interbody Fusion (OLIF) procedures from L2 to L5 in patients diagnosed with DDD, as defined above. Consult the labeling for the Infuse™ Bone Graft/Medtronic Interbody Fusion Device for information on the specific sizes of the Clydesdale™ 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. Additionally, the Clydesdale™ Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. Infuse™ Bone Graft is not indicated for use in patients with this condition. These patients should be skeletally mature and have had six months of nonoperative treatment. The Clydesdale™ Spinal System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. These implants may be implanted via a minimally invasive lateral approach.​

Risks Include
Adverse effects may occur when the device is used either with or without associated instrumentation. The potential risk of adverse effects as a result of movement and non-stabilization may increase in cases where associated complementary support is not employed.​

  • Potential adverse events include but are not limited to:​
  • Implant migration.​
  • Breakage of the device(s).​
  • Loss of proper spinal curvature, correction, height, and/or reduction.​
  • Early or late loosening or movement of the device(s).​

Please see the package insert for the complete list of indications, warnings, precautions, and other important medical information.​

INFUSE™ BONE GRAFT

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 I 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.

STEALTH-MIDAS™ AND STEALTH-MIDAS™ MR8 HIGH SPEED DRILL

INDICATIONS

The Stealth-Midas and Stealth-Midas MR8 Systems are indicated for the drilling, burring and removal of hard tissue and bone in spinal and cranial surgical procedures. Computer-assisted surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.
 
 


Caution: Federal Law (USA) restricts these devices for sale by or on the order of a physician. Refer to product instruction manual/package insert for instructions, warnings, precautions and contraindications. ​

Healthcare professionals must review the product technical manual prior to use for detailed disclosure. Please see the package insert or system Manual for the most complete list of Indications, Safety, and Warnings. Contact Customer Service or your Sales Representative or visit http://manuals.Medtronic.com for the most up-to-date revision of the package insert or the system manual.​

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