PILAR™ Technique for Cervical Fusion

The power of choice

Screw options that offer strong cervical fixation, lower anatomic risk^†,1

PILAR™ technique trajectory range is 25 to 45 degrees.

Meet the PILAR™ technique, a procedure with pedicle inlet screw options that offer less anatomic risk compared to a pedicle trajectory using a full pedicle screw.^†,1 The PILAR™ technique can achieve improved fixation and streamlined workflow benefits of a traditional pedicle screw without the traditional pitfalls of neurological and vascular risk.^†,1

Stronger

Stronger hold for lasting stability

The PILAR™ technique screw has demonstrated a 51% increase in pull-out strength compared to a lateral mass screw^‡,1

Infinity™ 2 OCT system details

Safer

Screw length options for risk control

With the PILAR™ technique, the screw stops short of neurovascular structures compared to pedicle trajectory with a full pedicle screw^†,1

Strategically selecting screw length allows you to further manage anatomic risk.^†,1

Simpler

Streamlined rod placement and clearer surgical access

The PILAR™ technique facilitates easier rod placement due to better screw alignment compared to lateral mass screws.^†,1

This minimizes hardware obstruction in the operative corridor compared to lateral mass screws and facilitates easier laminectomies.^†,1

Image courtesy of Christopher T. Martin, MD

Integrated Medtronic solutions for complete cervical fusion support

The AiBLE™ smart ecosystem, Midas Rex™ drill, and the Caption™ cervical stabilization system work together to streamline every stage of cervical fusion, from pre-op planning to intra-op precision and post-op stability.

StealthStation™ S8 navigation system

StealthStation™ navigation provides the intraoperative tool to implement the PILAR™ technique.

Indications, Safety, and WarningsThe StealthStation™ S8 system is intended as an aid for precisely locating anatomical structures in either open or percutaneous surgical procedures. The StealthStation™ system 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 the 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.The StealthStation™ S8 system with StealthStation™ cranial software is intended as an aid for 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 skull, can be identified relative to images of the anatomy. This can include, but is not limited to, the following cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures):

Tumor resections

Cranial biopsies

General ventricular catheter placement

Pediatric ventricular catheter placement

Depth electrode, lead, and probe placement

General localization

The StealthStation™ S8 system, with StealthStation™ S8 spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic 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 the spine or pelvis, can be identified relative to images of the anatomy.This can include the following spinal implant procedures, such as:

Pedicle screw placement

Iliosacral screw placement

Interbody device placement

Residual risksResidual risks related to the use of a Medtronic computer-assisted surgery system and its associated applications are the same as the residual risks for the procedures in which the system is used.ContraindicationsMedical conditions that contraindicate the use of a Medtronic computer-assisted surgery system and its associated applications include any medical conditions that may contraindicate the medical procedure itself.Warnings

The system hardware and software should be used only by qualified medical professionals who are trained in performing surgery and familiar with image-guided surgery systems.

If system navigation seems inaccurate and recommended steps to restore accuracy are not successful, abort use of the system.

Inspect all visible system components before use including the localizers that accompany your system (that is, the camera, the electromagnetic (EM) instrument interface, the side-mount emitter, or the flat emitter). If visibly damaged, do not use the system.

To avoid the risk of electrical shock, do not simultaneously touch the patient and the system input/output panel, mouse, keyboard, or batteries. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

Metallic and conductive objects in or near the electromagnetic navigation field can degrade navigational accuracy and navigation volume. If metallic distortion causes excessive error, navigation may be disabled. To restore navigation, move metallic and conductive objects away from the navigation field.

Electrical noise in or near the electromagnetic navigation field can degrade navigational accuracy. If electrical noise introduces excessive error, the system may automatically disable navigation. To restore navigation, move devices that produce electrical noise (such as electrocautery equipment and electric drills) away from the navigation field.

Prevent fluid from entering any part of the StealthStation™ S8 system. Shut down the system, disconnect the power, and allow the system to dry if you suspect fluids may have entered any part of the system.

Do not step on the base or legs of the system carts because the carts could tip over and cause injury.

The system is not suitable for use in the presence of a flammable, anesthetic mixture with air, oxygen, or nitrous oxide.

Do not modify the StealthStation™ S8 system without prior written consent from Medtronic Navigation, Inc. Prohibited modifications include but are not limited to altering, repairing, or replacing system components; altering software provided by Medtronic; updating the operating system or drivers; and installing any software that is not provided by Medtronic, including antivirus software. Secure the system to prevent unauthorized modifications. Unauthorized modifications could render the system unsafe or ineffective for its intended use.

Follow system component maintenance and care instructions.

The StealthStation™ S8 system camera cart contains a stereo system for music playback from a user provided audio player. This system may be capable of sound levels which can lead to permanent hearing loss at high volume. The volume is controlled at the user-provided audio player. For hearing safety, follow all instructions and warnings prescribed by the manufacturer of the user-provided player.

Stealth™ tractographyBecause tractography is based on the diffusion of water in the brain, any condition that alters the flow of water may alter the fiber tract results. For example, the presence of edema around a tumor, which is like a pool of water, can result in an incomplete tract. Because fiber tracts cross one another throughout the brain, tractography may result in a tract that crosses from one fiber tract to another or an incomplete tract. This limitation is more prevalent when using the standard diffusion tensor imaging (DTI) tract fidelity.Precautions

Federal law (United States) restricts this device to sale by or on the order of a physician.

Caution: The system and its associated applications contain no user-repairable parts. For repair or replacement of any part of the system or application, contact a Medtronic Navigation™ technical support representative.

To avoid interrupting navigation, do not use the StealthStation™ S8 system on battery power alone while the system is in use with a patient.

Periodically plug in the system to recharge the backup batteries. The backup batteries on the main cart and the camera cart are intended to keep the system operating for a short time if power is lost or disconnected. If the backup batteries are not charged, the system will shut down immediately when power is lost. The backup battery in the camera cart will recharge only when the two carts are connected to the cart-to-cart cable.

Before surgery, clean the system carts and other non-sterilizable system components according to the parameters in the StealthStation™ S8 system cleaning instructions (9735727).

The system mouse and keyboard are not designed for sterilization and may be damaged if sterilization is attempted.

System components are fragile. Use care when handling system components.

Keep the rear storage bin clear of extraneous materials which could block airflow through the perforated panel. Blocking air flow could result in excessive internal cart temperatures, which could degrade the system’s performance and longevity.

Avoid spilling fluids onto casters because fluid may impair the braking ability and the stability of the cart at rest on inclined surfaces.

Caption™ cervical stabilization system

Further reduce motion of the skull clamp with the Caption™ system. In a cadaver study, the motion of the skull clamp with the stabilizer was reduced as compared to no stabilizer:^†,§

53.6% reduction in AP motion
92.1% reduction in ML motion

The Infinity™ occipitocervical upper thoracic (OCT) system stabilizes the spine during C1 to C7 and T1 to T3 spinal fusions.

Infinity™ 2 OCT system

The Infinity™ 2 OCT system offers the screw options for the PILAR™ technique and provides the versatility to simplify even the most complex posterior cervical procedures.

Indications, Safety, and WarningsIndicationsThe Infinity™ OCT system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1 to T3:

Traumatic spinal fractures and/or traumatic dislocations

Instability or deformity

Failed previous fusions (e.g., pseudarthrosis)

Tumors involving the cervical spine

Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability

The Infinity™ OCT system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the Infinity™ OCT system may be connected to the CD Horizon™ spinal system and Vertex™ reconstruction system rods with the Infinity™ OCT system rod connectors. Transition rods with differing diameters may also be used to connect the Infinity™ OCT system to the CD Horizon™ spinal system.Refer to the CD Horizon™ spinal system package insert and Vertex™ reconstruction system package insert for a list of the indications of use. Note: The 3.0 mm multi-axial screw (MAS) requires the use of MAS Crosslink™ at each level in which the 3.0 mm screw is intended to be used.
The lateral offset connectors and MAS extension connectors are intended to be used with 3.5 mm and larger diameter multi-axial screws. The lateral offset connectors and MAS extension connectors are not intended to be used with 3.0 mm screws.RisksAlong with the benefits of this technology, there are also potential risks. Risks associated with the Infinity™ OCT system include, but are not limited to:

Disassembly, bending, and/or breakage of any or all of the components

Pressure on the skin from the component parts which could cause skin penetration, irritation, and/or pain, tissue or nerve damage, and/or scar formation

Midas Rex™ high-speed drill bit

The 2.0 by 25 mm Midas Rex™ drill bit was designed specifically to enable pilot hole creation and is compatible with the StealthStation™ navigation system.

Indications, Safety, and WarningsIndications for useThe Medtronic MR8™ drill system is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials in neurosurgical (cranial and craniofacial including craniotomy), ear, nose and throat (ENT), and maxillofacial, orthopedic, arthroscopic, spinal, sternotomy, and general surgical procedures.Additionally, the MR8™ drill system is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:

Lumbar microdiscectomy

Lumbar stenosis decompression

Posterior lumbar interbody fusion (PLIF)

Transforaminal lumbar interbody fusion (TLIF)

Anterior lumbar interbody fusion (ALIF)

Direct lateral interbody fusion (DLIF)

MR8™ system descriptionMR8™ pneumatic motorsPneumatic motors provide power to operate interchangeable, disposable surgical dissecting tools. These motors are designed to interface with a series of attachments and surgical dissecting tools using a standard quick-disconnect locking mechanism. Motors operate in the same manner whether controlled by a finger mechanism or PCU.MR8™ attachmentsAttachments are designed to align the surgical tools with the motor to provide support and stability during various surgical procedures. Attachment options include regular (straight, and angled), variable exposure (straight and angled), footed (craniotomies), and telescoping attachments and tubes. There are a variety of specialty attachments, such as the perforator, Jacobs chuck j-latch, and metal cutting that are also available. This allows flexibility with the length and style of attachment for surgeries.MR8™ surgical dissecting toolsSurgical dissecting tools are designed and intended to resect, drill, or saw soft and hard tissue, bone, biomaterials, and metals during various surgical procedures. The surgical dissecting tools vary in length and the distal tips of the tools vary in shape and style. The tip designs include the following universal shapes: acorn, match head, ball or round, cylinder, oval, and tapered or side cutting. Specialized tools such as metal cutters, twist drills, hole-makers, hole saws, and reverse tapered tools are also available.Residual risksResidual risks related to the use of the Medtronic Midas Rex™ MR8™ Pneumatic System are: General Surgical Complications, Thermal Injury, Tissue or Bone Damage, Nervous System Injury, Cerebrospinal Fluid Leakage, Infection, and Hearing Damage.ContraindicationsNone.Special noticesThe words warning, caution, and note have special meanings in this manual, and should be carefully reviewed:

Warning: A warning indicates that the personal safety of the patient or physician may be involved. Disregarding this information could result in injury to the patient or user.

Caution: A caution indicates that there is a risk of damaging equipment.

Note: A note is intended to provide additional information, which may be useful, but is not essential to complete the procedure.

WarningsSystem

The MR8™ system operator must be familiar with these instructions for use, its precautions, procedures, and safety issues.

The MR8™ system and its associated equipment should be used only by qualified medical professionals who are thoroughly trained and experienced in performing surgery with Medtronic surgery systems.

Always inspect the components before and after use for any damage. If damage is observed, do not use the damaged component until it is repaired by Medtronic or replaced.

Use adequate irrigation during dissection to prevent thermal necrosis.

Do not use an overheated device, as it may cause thermal injury to the patient or operator.

Heavy side loads and/or long operating periods may cause the device to overheat.

W6a

Never place an overheated motor on the patient or draping during the surgery.

W6b

Discontinue use and rest the motor by using it intermittently or wrap the motor/attachment interface with a moist sterile towel.

W6c

If the motor is passed off, the receiver should grasp the motor by the proximal end close to the motor hose.

Do not use excessive force to pry or push bone with the attachment or dissecting tool during surgery.

Use only dissecting tools specifically designed for use with this drill system. Match the nomenclature and color code on the MR8 dissecting tool packaging to the same nomenclature and color band on the MR8 attachment.

Do not use the MR8 system without proper cleaning and sterilization.

W10

Sterilize and dry the reusable device before storing. Decrease the likelihood of cross-contamination with timely sterilization. After each procedure, properly clean and sterilize all reusable system components.

W11

All service must be performed by Medtronic qualified personnel only.

The Midas Rex™ MR8™ pneumatic high-speed drill system

W12

Employ visualization, including the use of imaging techniques (for example, fluoroscopy, image guided surgery) when using rotating powered accessories. Discontinue the powered application if visualization to the surgical site is lost.

W13

Do not attempt to remove a dissecting tool or attachment while the motor is running, or when the motor or attachment is in an overheated state to prevent laceration of the user and/or cross contamination through a compromised glove.

W14

Do not immerse the system components, except when recommended by the cleaning instructions in this Instructions for Use.

W15

The MR8 motors should only be operated when the attachment is in the fully locked position.

W16

Do not modify any components of the system; performance could be diminished.

W17

Do not use the MR8 system if the motor continues to run after releasing the foot pedal or finger lever.

W18

Do not place the motor, attachment, or dissecting tool on the patient or in an unsecured location during surgery.

W19

Do not use an attachment and dissecting tool combination that results in tool flail or excessive vibration.

W20

Do not attempt to run the MR8 motors immediately after autoclaving. Allow an adequate cooling period after steam sterilization.

W21

Verify functionality prior to reuse:

W21a

Conduct a visual inspection of the hose for cracks, tears, or corrosion.

W21b

Check attachments for proper appearance. Install the attachment and dissecting tool, then briefly the run motor.

W21c

Check motor for overheating.

W21d

Check attachment for overheating.

W213

Check dissecting tool for flail.

W21f

Check motor for leaking lubricant.

W22

Do not place MR8 motor in the proximity of a magnetic field, such as magnetic drape or Magnetic Resonance Imaging (MRI) equipment to avoid inadvertent motor activation.

W23

Do not use metal-cutting attachment or tools to cut/resect bone.

W24

For metal transection, observe the following safety guidelines:

W24a

Wear eye protection.

W24b

Irrigate well to cool the cutting surfaces.

W24c

Protect the wound site from metal debris.

W24d

Use a clamp or grasping device to control loose fragments during transection of any metal component.

W25

Do not use any parts other than Medtronic system components, as damage or substandard performance could result.

W26

When using MR8 variable exposure attachments, surgeons should become familiar with the performance of dissecting tools before use and should explore the effect of various levels of tool exposure on tool stability. If the tool exhibits excessive chatter, vibration, or movement, decrease the tool exposure.

W27

Motors and attachments may fail due to extended use resulting in component(s) detaching and falling from the motor or attachment and may cause patient injury.

W28

When using the MR8 non-DK variable exposure attachments, ensure that the attachment is still in the locked position after each adjustment of the tool exposure. Attempting to increase the tool exposure too far may result in the attachment accidentally being unlocked.

W29

Remove MR8 footed attachments cautiously and slowly, as per instructions to avoid injury to the operator.

W30

Excessive side loading could cause non-DK angled attachments to unlock accidentally from motor.

W31

Place MR8 pneumatic finger-controlled motor in Safe mode (“0”) while not in use.

W32

When not operating the motor, eliminate accidental foot control activation.

W33

Do not use the MR8 system in the presence of flammable anesthetics to avoid potential ignition or explosion of gases.

W34

Do not operate the MR8 system without eye protection.

W35

Failure to properly secure the lubricant/diffuser or oil cartridge may cause injury to operator and/or operating room staff.

W36

Do not use the pneumatic control unit to operate systems other than the Midas Rex devices.

W37

You must ensure the adapter is fully threaded onto the regulator hose and that the adapter is fully threaded/connected to the corresponding wall outlet before operating the pneumatic system.

W38

Do not attempt to use a motor that is leaking lubricant. MR8 motors which fail due to extended use and/or lubricant seal failure may allow foreign matter to migrate or emit from the tool collet end of the motor. Non-sterile fluid may leak into the surgical site. As a result, measures may be required to protect the patient from infection, per the physician’s discretion.

W39

Do not load more than one MR8 motor inside the instrument tray per sterilization cycle.

W40

Do not wrap the rigid sterilization container.

W41

The MR8 system operator should take appropriate measures in ensuring that sensitive anatomy is protected during drilling and use of the MR8 system.

W42

Use the MR8 instrument tray and the rigid sterilization container for sterilizing the re-usable MR8 devices only.

W43

Do not use the instrument tray and rigid sterilization container for cleaning or disinfection of the re-usable devices.

W44

Do not use alkaline cleaning for the instrument tray or the rigid sterilization container.

W45

Do not sterilize and supply for surgical use any device that is not visibly clean and free of particulates. If particulates are present, repeat reprocessing, starting with the Preparation for Cleaning step.

W46

Use the instrument tray and the rigid sterilization container for sterilization only. The MR8 system devices must be cleaned separate from the trays.

W47

Devices cannot be sterilized to an adequate Sterility Assurance Level (SAL) without prior cleaning and decontamination.

System hoses

W48

Do not pinch, kink, obstruct, cut, tear, or step on the motor exhaust hose. This may cause the hose to burst, potentially injuring the patient or user.

Tools and disposable components

W49

Tool flutes are sharp and may perforate surgical gloves. Tool stems may be grasped with a hemostat to aid in installation and removal. Use methods at the operative site to control bleeding that do not compromise patient safety during surgery.

W50

Keep the cutting area of the tool away from fingers and loose clothing to prevent laceration of the user and cross-contamination through a compromised glove.

W51

A tool’s size and geometry may create excessive vibration at certain speeds. Increase or decrease the speed of the motor to prevent vibration. Change to a new tool to prevent unintended tissue damage.

W52

Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause patient hearing damage.

W53

Consult the cranial perforator manufacturer device labeling for the recommended speed specifications.

W54

Tools with “L” identification are longer tools intended for light bone dissection. The increased tool head/stem configuration may affect dissection stability.

W55

Dissecting tools are for single-use only. Do not attempt to sterilize them. The dissecting tools are packed sterile and not intended for repeat use. To prevent contamination, use only once.

W56

Excessive pressure applied to a tool may cause tool fracture. Should a tool fracture in use, extreme care must be exercised to ensure that all the fragments of the tool are removed from the patient. Unremoved tool fragments may cause tissue damage to the patient.

W57

Do not sterilize disposable devices. They are sterilized at the factory and are not intended for repeat use. To prevent contamination, use only once.

W58

Do not use an accessory if its packaging is damaged or opened outside the sterile field. Sterility may be compromised if packaging is opened or damaged.

W59

Do not use dull tools. Use of dull tools can reduce cutting effectiveness and can cause the motor temperature to increase.

W60

Fluted tools are designed to be used in forward mode. Diamond tools may be used in forward or reverse modes.

W61

Exposure of tool packaging to ambient light for extended periods of time may cause damage to packaging.

Pneumatic control unit

W62

Do not carry pneumatic control unit by the N2 DISS pressure hose.

W63

Do not disassemble equipment before gas pressure is released from the pneumatic control unit and associated hoses.

Cautions

When using a non-DK angled attachment, hold the motor assembly by the attachment so that the attachment does not inadvertently loosen from the motor.

Do not use a twist drill dissecting tool at an operating pressure over 80 psi (5.5 bar).

Use of a washer-disinfector for cleaning may cause a pre-mature degradation in performance.

Remove devices from instrument tray before placing into washer-disinfector and allow devices to drain. Orient devices in the washer-disinfector by following manufacturer recommendations.

Do not use low-temperature hydrogen peroxide gas plasma sterilization due to the lumen internal diameter and length restrictions.

Do not use low-temperature liquid peracetic acid sterilization due to immersion procedure.

Remove and discard accessories following local regulations for disposal of contaminated materials.

Do not use an MR8 motor without a lubricant/diffuser or oiler cartridge installed.

Do not use chlorine-based or corrosive cleaning agents such as bleach, lye, acetone, sodium hypochlorite or bleach, sodium hydroxide, formic acid, or solutions containing glutaraldehyde.

C10

Do not use a lubricant/diffuser or oiler cartridge for more than one hour of drill time.

C11

Do not reuse or attempt to refill a lubricant/diffuser or oiler cartridge. It is a single-use product.

C12

Do not use a lubricant/diffuser or oiler cartridge if it appears to be damaged or if the inner foil seal is punctured.

C13

Devices should be cleaned within 30 minutes (30:00) of use to limit fixation of contaminants.

C14

Do not use ultrasonic cleaner. Review the washer-disinfector cautions before using this cleaning method.

C15

Do not expose these devices to sterilization temperatures greater than 137 C (279 F). Exposure to temperatures greater than 137 C (279 F) may impact the performance of the device and also the efficacy of the sterilization cycle.

C16

Because of the variability in cleaning efficiencies and sterilizer operating parameters, all given parameters (temperature, time, etcetera) should be validated by persons who have training and expertise in sterilization processes. Deviation from the recommended sterilization processes is at the risk of the user facility.

UNiD™ adaptive spine intelligence

UNiD™ ASI can help with planning and custom rod creation for your patient’s needs.

Indications, Safety, and WarningsCD Horizon™ system indicationsThe 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™ 3.5 mm rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5 mm 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.RisksAll of the possible adverse events associated with spinal fusion surgery without instrumentation are possible. With instrumentation, a listing of potential adverse events includes:

Disassembly, bending, or breakage of any or all of the components

Early or late loosening of any or all of the components

Disassembly, bending, or breakage of any or all of the components

Post-operative change in spinal curvature, loss of correction, height, or reduction

Infection

PASS LP™ system descriptionThe internal fixation devices are composed of screws, hooks, rods, plates, cross links, connection and locking devices .The range of different sizes and shapes of the implants allows the surgeon to adapt to the pathology and morphology of each of his patients. The implants are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, with the exception of the rods intended for in situ bending which are manufactured in non-alloyed titanium (CP titanium) conforming to ISO 5832-2 specifications and ASTM F67 specifications and the CoCr rods which are manufactured in cobalt chrome alloy Co-Cr28Mo6 conforming to ISO 5832-12 specifications and ASTM F1537 specifications. The patient-specific rod has been designed and manufactured for one specific patient. The patient-specific rod should be used during surgery for this patient only and should not be reused (single use only). Refer to the surgical technique brochure for additional information. If this patient-specific rod does not perform as intended, use the standard PASS LP rod to complete the surgery. Under no circumstances are the implants reusable.IndicationsThe PASS LP™ spinal systems include a pedicle system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine:

Fractures

Dislocation

Failed previous fusion (pseudarthrosis)

Spinal stenosis

Degenerative spondylolisthesis with objective evidence of neurological impairment

Spinal deformations such as scoliosis or kyphosis

Loss of stability due to tumors

The PASS LP™ spinal systems are also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5–S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.The PASS LP™ also include hooks and rods and sacral/iliac screws indicated for 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, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis and failed previous fusion.Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP™ spinal system implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PASS LP™ spinal system is intended to be used with allograft and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.Warning: The safety and effectiveness of this device has not been established for use as part of a growing rod construct. This device is only intended to be used when definitive fusion is being performed at all instrumented levels.RisksIn addition to the risks associated with surgery of the spine without instrumentation, a number of possible undesirable effects may occur with instrumented surgery (including but not limited to):

Detachment, deformation, mobilization, slipping, breakage of one or all of the components

Pain due to the surgery, the fracture, deformation and or migration of an implant

Fracture of the pedicle during insertion of a pedicular screw

Postoperative loss of correction and/or reduction of the spine, partial or total loss of the corrections achieved

UNiD™ spine analyzer indicationsThe UNiD™ spine analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons and service providers to perform generic as well as spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.

† Cadaveric results may not be indicative of clinical performance.

‡ Validated in a cadaveric biomechanical model.

§ Medtronic data on file.

PILAR™ technique