Medtronic 3491210 Instructions for Use

Perimeter™ Interbody Fusion Device M708348B767E Rev. B

2020-10-08

IMPORTANT INFORMATION ON THE PERIMETER™ INTERBODY FUSION DEVICE

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 instructed as to its mechanical and material applications and limitations. This
device is manufactured in medical grade polyetheretherketon (PEEK) or titanium alloy (titanium-6aluminum-4vanadium ELI).
This interbody device is provided sterile or non-sterile. Refer to the package label for sterility information.

DESCRIPTION

The Perimeter™ Interbody Fusion Device consists of cages of various widths and heights which can be inserted between two
lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. 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.The Perimeter
Device is to be used with supplemental fixation instrumentation.

The device is offered in titanium alloy (titanium-6aluminum-4vanadium ELI) or PEEK. This interbody device is offered sterile or
non-sterile. Refer to the package label for implant sterility information.

The Perimeter
length, and between 19mm and 38mm in width. An array of lordosis options are provided for this device spanning from 4° to 15°
of angulation. Both the PEEK and Titanium Alloy (Titanium-6Aluminum-4Vanadium ELI) devices are designed with teeth across
both the superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus providing expulsion
resistance. Additionally, the titanium alloy version of this device offers lateral windows for visibility of the autogenous bone
and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with
bone marrow aspirate.

Based on fatigue testing results, when using the Perimeter™ Interbody Fusion Device, the physician/surgeon should consider
levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact performance of this
system.

Never use stainless steel and titanium implant components in the same construct.
Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy may be used together. Never

use titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct.
PEEK implants may be used with stainless steel, titanium, or cobalt-chromium-molybdenum alloy implants.

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

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Interbody Fusion Device is offered in a variety of sizes ranging from 8mm to 20mm in height, 15mm to 28mm in

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Interbody

INDICATIONS

The Perimeter™ 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. These implants may be implanted via a variety of open or minimally invasive
approaches. These approaches include anterior, lateral, and oblique. These devices are intended to be used with supplemental
fixation instrumentation, which has been cleared 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 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.
▪ Cases not needing a fusion.
▪ Cases not described in the indications.
▪ Patients unwilling to cooperate with postoperative instructions.
▪ Patients with a known hereditary or acquired bone friability or calcification problem.
▪ Pediatric cases, nor where the patient still has general skeletal growth.
▪ Spondylolisthesis unable to be reduced to Grade 1.
▪ Cases where implant components selected for use would be too large or too small to achieve a successful result.
▪ Cases requiring mixing metals from two different components or systems.
▪ Patients having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
▪ Patients in which implant use would interfere with anatomical structures or expected physiological performance.
▪ Prior fusion at the level to be treated.

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

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

POTENTIAL ADVERSE EVENTS

Adverse events may occur when the device is used either with or without associated instrumentation.
Risk of adverse events 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 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.

▪ Cerebral spinal fluid leakage.
▪ Haemorrhage 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.
▪ Death.

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 the 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 the successful use of the system. Further, proper selection and
compliance of the patient will greatly affect results. 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.

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

This device was designed for single patient use only. Do not reuse or reprocess this product. Reuse or reprocessing 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

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.

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, reuse a Perimeter
undamaged, it may have small defects or internal stress patterns that may lead to early breakage.

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Interbody Fusion Device. Even when a removed device appears

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 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, all devices should be cleaned and sterilized before use. Additional sterile components should be

available in case of any unexpected need.

INTRAOPERATIVE

▪ Instructions in any available Perimeter

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Interbody Fusion Device 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 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 the 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.

▪ Perimeter

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implants are interbody devices and are intended to stabilize the operative area during fusion.

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

PACKAGING

Devices are supplied sterile and non-sterile. Packages for sterile devices should be intact upon receipt. Once the seal on the
package is broken, the product should not be re-sterilized. 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 Medtronic, implants used in
surgery must be sterilized by the hospital prior to use. Remove all packaging materials prior to sterilization. Only sterile products
should be placed in the operative field. Unless specified elsewhere, these products are recommended to be steam sterilized by
the hospital using one of sets of parameters in Table 1.

The sterilization cycles listed in Table 2 are not considered by the Food and Drug Administration (FDA) to be standard
sterilization cycles. It is 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 FDA for the selected sterilization
cycle specifications (time and temperature).

Table 1: 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

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

Table 2: 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

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.

Sterilization parameters listed in Tables 1 and 2 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.

For detailed instructions for use specific to the instruments used with Perimeter
disassembly, cleaning, and sterilization instructions, refer to the following documents packaged with the instruments or available
by document number at http://manuals.medtronic.com:

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Interbody Fusion Device, including

▪ “IMPORTANT INFORMATION ON THE REUSABLE INSTRUMENTS USED WITH Perimeter

DEVICE”, part number M708348B081

▪ “IMPORTANT INFORMATION ON THE CATALYST

®

REUSABLE INSTRUMENTS”, part number M708348B123.

MINIMUM DRY TIME

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INTERBODY FUSION

1

PRODUCT COMPLAINTS

For product problems, contact Medtronic.

MRI INFORMATION

The Perimeter™ Interbody Fusion Device has not been evaluated for safety and compatibility in the MR environment. It has not
been tested for heating, migration, or image artifact in the MR environment. The safety of the Perimeter™ Interbody Fusion
Device in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

FURTHER INFORMATION

Recommended directions for use of this system (surgical operative techniques) 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

Consult instructions for use at this website.

Catalogue number

Batch code

Manufacturer

Medtronic B.V.

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

Non-sterile

For US audiences only

Sterilized using irradiation

Use-by date