Medtronic 7771023 Instructions for Use

Elevate™ Spinal System M708348B559E Rev. D

2020-10-13

IMPORTANT INFORMATION ON THE ELEVATE™ SPINAL SYSTEM

PURPOSE

This device is a fusion device intended for stabilization and to promote bone fusion during the normal healing process following
surgical correction of disorders of the spine. The product should be implanted only by a physician thoroughly knowledgeable in
the implant's material and surgical aspects, and who has been instructed as to its mechanical and material applications and
limitations.

DESCRIPTION

The Elevate™ Spinal System is an expandable PEEK, tantalum, and titanium alloy interbody device consisting of various
lengths and starting heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and
correction during lumbar interbody fusion surgeries. The Elevate™ Spinal System expands for adjustable lordosis and height to
match patient anatomy. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft
bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow
aspirate. Implants may be implanted via a posterior or transforaminal approach and the procedure may be open or minimally
invasive. The Elevate™ Spinal System can be implanted unilaterally and bilaterally. The Elevate™ Spinal System is intended to
be inserted with Elevate™ Spinal System reusable instruments.

No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use
are specifically excluded.

INDICATIONS

The Elevate™ Spinal System Expandable Interbody Fusion Device is indicated for interbody fusion with autogenous bone
and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with
bone marrow aspirate 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 or 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. Implants may be implanted via an open or a minimally
invasive posterior approach. Implants are to be used with autogenous bone and/or allograft bone graft comprised of cancellous
and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. These devices are intended
to be used with supplemental fixation instrumentation, cleared by the FDA for use in the lumbar spine.

CONTRAINDICATIONS

This device is not intended for cervical spine use.
Contraindications include:

▪ Infection local to the operative site.
▪ Signs of local inflammation.
▪ Fever or leukocytosis.
▪ Morbid obesity.
▪ Pregnancy.
▪ Mental illness.
▪ Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors or

congenital abnormalities, fracture local to the operating site, elevation of sedimentation rate unexplained by other diseases,
elevation of white blood count (WBC), or a marked left shift in the WBC differential count.

▪ Suspected or documented allergy or intolerance to composite materials.
▪ Any case not needing a fusion.
▪ Any case not described in the Indications.
▪ Any patient unwilling to cooperate with postoperative instructions.
▪ Patients with a known hereditary or acquired bone friability or calcification problem should not be considered for this type of

surgery.

▪ These devices must not be used for pediatric cases, nor where the patient still has general skeletal growth.
▪ Spondylolisthesis unable to be reduced to Grade 1.
▪ Any case where implant selected would be too large or too small to achieve a successful result.

▪ Any case that requires the mixing of metals from two different components or systems.
▪ Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
▪ Any patient in which implant use would interfere with anatomical structures or expected physiological performance.
▪ Prior fusion at the level to be treated.

Note: although not absolute contraindications, conditions to be considered as potential factors for not using this device include:

▪ Severe bone resorption.
▪ Osteomalacia.
▪ Severe osteoporosis.

Consideration that the segmental stability can be affected by a variety of factors.

POTENTIAL ADVERSE EVENTS

Adverse effects may occur when the device is used either with or without associated instrumentation.
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:

▪ Implant migration.
▪ Breakage of device.
▪ Foreign body reaction to the implants including possible tumor formation, auto immune disease, and/or scarring.
▪ Pressure on the surrounding tissues or organs.
▪ Loss of proper spinal curvature, correction, height, and/or reduction.
▪ Infection.
▪ Bone fracture or stress shielding at, above, or below the level of surgery.
▪ Non-union (or pseudoarthrosis).
▪ Loss of neurological function, appearance of radiculopathy, dural tears, and/or development of pain.
▪ Neurovascular compromise including paralysis, temporary or permanent retrograde ejaculation in males, or other types of

serious injury and Cerebral spinal fluid leakage.

▪ Hemorrhage of blood vessels and/or hematomas.
▪ Discitis, arachnoiditis, and/or other types of inflammation.
▪ Deep venous thrombosis, thrombophlebitis, and/or pulmonary embolus.
▪ Bone graft donor site complication.
▪ Inability to resume activities of normal daily living.
▪ Early or late loosening or movement of device.
▪ Urinary retention, loss of bladder control, or other types of urological system compromise.
▪ Scar formation possibly causing neurological compromise or compression around nerves and/or pain.
▪ Fracture, microfracture, resorption, damage, or penetration of any spinal bone (including the sacrum, pedicles, and/or

vertebral body) and/or bone graft or bone graft harvest site at, above, and/or below the level of surgery.

▪ Retropulsed graft.
▪ Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of surgery.
▪ Loss of or increase in spinal mobility or function.
▪ Reproductive system compromise including sterility, loss of consortium, and sexual dysfunction.
▪ Development of respiratory problems (e.g., pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.).
▪ Change in mental status.
▪ Cessation of potential growth of the operated portion of the spine.
▪ Death.

Note: additional surgery might become necessary to correct adverse effects.

WARNINGS AND PRECAUTIONS

A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where other
patient conditions may compromise results. Use of this product without autogenous bone and/or allograft bone graft comprised
of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate or in cases
that do not develop a union will not be successful.

Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and correct selection and
placement of implants are important considerations in successful use of the system. Further, the proper selection and the
compliance of the patient will greatly affect results. Trial distractors enable a simple and safe size destination. Over-distraction is
to be avoided. Patients who smoke were shown to have a reduced incidence of bone fusion. These patients should be advised
of this fact and warned of this consequence. Obese, malnourished, and/or alcohol/drug abuse patients and those with poor
muscle and bone quality and/or nerve paralysis are also poor candidates for spinal fusion.

When used in deformity procedures, undersizing the implant may limit endplate engagement and potentially lead to implant
migration and/or expulsion.

Patients with previous spinal surgery at the levels to be treated may have different clinical outcomes compared to those without
a previous spinal surgery.

Document the used implants per patient with REF and LOT, so the tracking, which is required by law, is guaranteed. Implants
are only for single use. Do not re-process or re-use devices labeled as single use devices. Re-processing or re-use of single

use devices may compromise the structural integrity of the device and/or create a risk of contamination of the device, which
could result in patient injury, illness, or death.

Physician note: although the physician is the learned intermediary between the company and the patient, the important medical
information in this document should be conveyed to the patient.

For US audiences only.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

IMPLANT SELECTION

Selection of proper size, shape, and design of the implant for each patient is crucial to success of the procedure. Surgical
implants are subject to repeated stresses in use, and their strength is limited by the need to adapt the design to the human
anatomy. Unless great care is taken in patient selection, placement of the implant, and postoperative management to minimize
stresses on the implant, such stresses may cause material fatigue and consequent breakage or loosening of the device before
the fusion process is complete, which may result in further injury or the need to remove the device prematurely.

Tables 1 and 2 provide details on implant size ranges.

Table 1: Standard Implant Size Ranges

Expansion height (mm)

16 8˚ 8˚

15 8˚ 7˚ 8˚ 7˚

14 8˚ 7˚ 8˚ 6˚ 8˚ 7˚ 5˚

13 8˚ 7˚ 4˚ 8˚ 5˚ 4˚ 8˚ 7˚ 5˚ 3˚

12 8˚ 7˚ 4˚ 1˚ 8˚ 5˚ 3˚ 1˚ 7˚ 5˚ 3˚ 1˚

11 7˚ 4˚ 1˚ 0˚ 5˚ 3˚ 1˚ 0˚ 5˚ 3˚ 1˚ 0˚

10 4

91˚ 0˚ 1˚ 0˚ 1˚ 0˚

80˚ 0˚ 0˚

Length 23mm Length 28mm Length 32mm

Insert height (mm)

8910118910 11891011

˚ 1˚ 0˚ 3˚ 1˚ 0˚ 3˚ 1˚ 0˚

Table 2: Extra Lordotic Implant Size Ranges

Expansion height (mm)

7 8 9 10 11 7 8 9 10 11 7 8 9 10 11

16 13˚ 12˚

15 13˚ 11˚ 9˚ 10˚ 8˚

14 13˚ 8˚ 11˚ 10˚ 7˚ 10˚ 8˚ 6˚

13 13˚ 8˚ 4˚ 11˚ 10˚ 7˚ 4˚ 10˚ 8˚ 6˚ 3˚

12 13˚ 8˚ 5˚ 1˚ 11˚ 9˚ 7˚ 4˚ 1˚ 10˚ 8˚ 5˚ 3˚ 1˚

11 13˚ 8˚ 5˚ 1˚ 0˚ 9˚ 7˚ 4˚

10 8˚ 5˚ 1˚ 0˚ 5˚ 4˚ 1˚ 0˚ 5˚ 3˚ 1˚ 0˚

94˚ 1˚ 0˚ 3˚ 1˚ 0˚ 3˚ 1˚ 0˚

81˚ 0˚ 1˚ 0˚ 1˚ 0˚

70˚ 0˚ 0˚

Length 23mm Length 28mm Length 32mm

Insert height (mm)

1˚ 0˚ 7˚ 5˚ 3˚ 1˚ 0˚

DEVICE FIXATION

Installation and positional adjustment of implants must only be done with special ancillary instruments and equipment supplied
by Medtronic. In the interests of patient safety, it is therefore recommended that Medtronic implants are not used with devices
from any other source.

Never, under any circumstances, re-use an Elevate™ Spinal System implant. Even when a removed device appears
undamaged, it may have small defects or internal stress patterns that may lead to early breakage.

PREOPERATIVE

▪ Only patients that meet the criteria described in the indications should be selected.
▪ Patient conditions and/or predispositions such as those addressed in the contraindications should be avoided.
▪ Care should be taken when handling and storing device. They should not be scratched or damaged. Devices should be

protected during storage especially from corrosive environments.

▪ The surgeon should be familiar with the various devices before use and should personally verify all devices are present

before surgery.

▪ The size of device for the case should be determined prior to surgery. An adequate inventory of implant sizes should be

available at the time of surgery including sizes larger and smaller than those expected to be used.

▪ Unless supplied sterile, implants should be sterilized before use. Additional sterile implants should be available in case of

any unexpected need.

INTRAOPERATIVE

▪ Instructions for Elevate™ Spinal System surgical technique manual should be carefully followed.
▪ At all times, extreme caution should be used around the spinal cord and nerve roots. Damage to nerves will cause loss of

neurological functions.

▪ Breakage, slippage, or misuse of instruments or implants may cause injury to the patient or operative personnel.
▪ To ensure proper fusion below and around the location of the fusion, autogenous bone and/or allograft bone graft

comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow
aspirate must be used.

▪ Bone cement should not be used. This material may make removal of these components difficult or impossible. Heat

generated from the curing process may damage or deform PEEK devices.

POSTOPERATIVE

The physician’s postoperative directions and warnings to the patient and the corresponding patient compliance are extremely
important.

▪ Detailed instructions on use and limitations of the device should be given to the patient. The patient must be warned that

loosening, and/or breakage of device are complications which may occur as result of early or excessive weight-bearing,
muscular activity, or sudden jolts or shock to the spine.

▪ The patient should be advised not to smoke or consume excess alcohol during period of the bone fusion process.
▪ The patient should be advised of the inability to bend at the point of spinal fusion and taught to compensate for this

permanent physical restriction in body motion.

▪ It is important that immobilization of union is established and confirmed by roentgenographic examination. If a non-union

develops or if components loosen, migrate, and/or break, devices should be revised and/or removed immediately before
serious injury occurs.

▪ Elevate™ Spinal System implants are interbody devices and are intended to stabilize the operative area during the fusion

process.

▪ Retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible.

MRI INFORMATION

MR Conditional

The Elevate™ Spinal System was determined to be MR Conditional based on comparison to previously evaluated Medtronic
products. A patient with this device can be safely scanned immediately after device placement under the following conditions:

Static Magnetic Field

▪ Static magnetic field of 1.5 and 3.0 Tesla.
▪ Maximum spatial gradient magnetic field of 3000 Gauss/cm or less.
▪ Maximum whole body average specific absorption rate (SAR) of 2.0 W/kg or less under normal operating mode, for 15

minutes of scanning per pulse sequence.

MRI-Related Heating

In non-clinical testing, a worst case interbody device representative of the Elevate™ Spinal System produced the following
temperature rises during MRI performed for 15min of scanning (i.e. per pulse sequence) in 1.5 Tesla/64 MHz MR system
(Magnetom, Siemens Medical Solutions, Malvern, PA. Software Numaris/4, Version Syngo MR 2002B DHHS Active-shielded,
horizontal field scanner) and 3.0 Tesla/128 MHz (Excite, HDx, Software 14X.M5, General Electric Healthcare, Milwaukee, WI)
MR systems:

Table 3: Temperature Rise During MRI

1.5 Tesla 3.0 Tesla

MR system reported, whole body averaged SAR 2.9 W/kg 2.9 W/kg
Calorimetry measured values, whole body averaged SAR 2.1 W/kg 2.7 W/kg
Highest temperature change +1.8˚C+1.7˚C

Artifact Information

MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the
Elevate™ Spinal System. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may
be necessary.

MRI Patient Counseling Information

Physicians should inform the patient of the following information about Magnetic Resonance Imaging (MRI) with respect to the
Elevate™ Spinal System:

▪ Elevate™ Spinal System performance was established for MRI systems at field strengths of 1.5 and 3.0 Tesla.
▪ During MRI, the patient may notice a warming sensation around the implant or feel a tingling sensation. If the warming or

tingling sensation is uncomfortable, the patient should communicate this to the MR technologist, the MRI should be stopped
and the settings adjusted to reduce or eliminate the sensation. The highest temperature change observed in non-clinical
testing was +1.8ºC (associated with specific conditions listed above).

▪ Additionally, the metal in the implant may cause the MRI image to be distorted in the area around the implant. The MRI can

be adjusted to minimize image distortion.

Physicians should instruct patients to:

▪ Informhealthcare personnel (e.g. doctor or MR technologist) they have an implanted interbody device prior to receiving an

MRI.

▪ The patient’s doctor will recommend whether or not an MRI is appropriate.

If the Elevate™ Spinal System is used in connection with any device which is not MR Conditional, be advised this
combination was not tested in the MR environment and, therefore, higher heating and possible injury to the patient may
occur.

The Elevate™ Spinal System instruments should not be introduced into the MR environment.

PACKAGING

Implants are supplied sterile. Packaging should be intact upon receipt. Once the seal on the sterile package is broken, the
product should not be re-sterilized. The Elevate™ Spinal System implants are packed in a double barrier sterile configuration.
Storage conditions must guarantee the integrity of the package and implant.

If a loaner or consignment system is used, all sets should be carefully checked for completeness and all devices should be
carefully checked to ensure there is no damage prior to use. Damaged packages or products should not be used, and should be
returned to Medtronic.

STERILIZATION

Unless marked sterile and clearly labeled as such in an unopened sterile package provided by the company, all implants used in
surgery must be sterilized by the hospital prior to use and all instruments must be cleaned and sterilized by the hospital prior to
use. Remove all packaging materials prior to cleaning and sterilization. Only sterile products should be placed in the operative
field. Unless specified elsewhere, these devices are recommended to be steam sterilized by the hospital using one of the
following set of process parameters:

Table 4: Sterilization Cycle Parameters for the US and Its Territories

Method Cycle Temperature Exposure time

Steam Gravity displacement 250°F (121°C) 30 Minutes 30 Minutes
Steam Gravity displacement 270°F (132°C) 15 Minutes 30 Minutes
Steam Gravity displacement 275°F (135°C) 10 Minutes 30 Minutes
Steam Dynamic-air-removal 270°F (132°C) 4 Minutes 30 Minutes
Steam Dynamic-air-removal 275°F (135°C) 3 Minutes 16 Minutes

Minimum dry time

1

Note: it is the end user’s responsibility to use only sterilizers and accessories (such as sterilization wraps, sterilization pouches,
chemical indicators, biological indicators, and sterilization cassettes) cleared by the Food and Drug Administration (FDA) for the
selected sterilization cycle specifications (time and temperature). The sterilization cycles listed in Table 5 are not considered by
the FDA to be standard sterilization cycles.

For medical facilities located outside the US and Its territories: some non-US health care authorities recommend sterilization
according to these parameters so as to minimize the potential risk of transmission of Creutzfeldt-Jakob disease, especially of
surgical instruments that could come into contact with the central nervous system.

Table 5: Sterilization Cycle Parameters for Medical Facilities Outside the US and Its Territories

Method Cycle Temperature Exposure time

Steam Gravity displacement 273°F (134°C) 20 Minutes 30 Minutes
Steam Dynamic-air-removal 273°F (134°C) 4 Minutes 30 Minutes
Steam Dynamic-air-removal 273°F (134°C) 20 Minutes 30 Minutes

1

The minimum dry times were validated using sterilizers having vacuum drying capabilities. Drying cycles using ambient

atmospheric pressure may require longer dry times. Refer to the sterilizer manufacturer’s recommendations.
Note: chamber size and chamber load differences may exist between industrial and health care facility sterilizer models. The

sterilization parameters listed in Tables 4 and 5 can be achieved in both health care facility and larger, industrial sterilizer
models. Because of the many variables involved in sterilization, each medical facility should calibrate and verify the sterilization
process (e.g. temperatures, times) used for their equipment.

Refer to the Medtronic Reusable Instrument package insert (0380035) of the supplemental instrumentation for sterilization and
cleaning information.

Minimum dry time

1

PRODUCT COMPLAINTS

To report product problems, contact Medtronic.

FURTHER INFORMATION

Recommended directions for use of this system (surgical operative technique) are available at no charge upon request. If further
information is required, contact Medtronic.

©2020 Medtronic Sofamor Danek USA, Inc. All rights reserved.

Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place
Memphis, TN 38132
Telephone: [phone] (USA)

901 396 3133 (Outside USA)

Fax: [phone]

EXPLANATION OF SYMBOLS

Authorized representative in the European Community

CAUTION: Federal law (USA) restricts these devices to
sale by or on the order of a physician.

Do not re-use

Batch code

Manufacturer

Catalogue number

For US audiences only

The Device complies with European Directive MDD
93/42/EEC

Medtronic B.V.

Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00

The Device complies with European Directive MDD
93/42/EEC

Sterilized using irradiation

Use-by date

MR Conditional

Do not use if package is damaged

Consult instructions for use at this website.