Medtronic 74200001255 Instructions for Use

RIALTO™ SI Fusion System M708348B480E Rev. A

2016-08-01

IMPORTANT INFORMATION ON THE RIALTO™ SI FUSION SYSTEM

PURPOSE

This device is a fusion device intended for stabilization and to promote bone fusion of the sacroiliac joint. 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 from medical grade titanium alloy and is
provided sterile.

DESCRIPTION

The RIALTO™ SI Fusion System consists of cannulated devices of various widths and lengths used to provide stabilization
when fusion of the sacroiliac joint is desired. Autograft and/or allograft may be placed in conjunction with the RIALTO™ SI
Fusion System. This device may be implanted via a minimally invasive approach.

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

Never use titanium or titanium alloy implants with stainless steel in the same construct.

INDICATIONS

The RIALTO™ SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and
degenerative sacroiliitis.

CONTRAINDICATIONS

The RIALTO™ SI Fusion System is contraindicated for patients with the following conditions:

▪ Deformities.
▪ Tumor resection.
▪ Infection local to the operative site and/or signs of local inflammation.
▪ Suspected or documented allergy or intolerance to the component materials.

POTENTIAL ADVERSE EVENTS

The following are potential adverse events which should be understood by the surgeon and explained to the patient. These do
not include all adverse events, which can occur with any surgical procedure, but are important factors to consider which are
specific to metallic internal stabilization devices. Potential adverse events specific to this device are:

▪ Post-operative infection, wound necrosis, or wound dehiscence.
▪ Pain, discomfort, or abnormal sensations caused by the presence of the implant.
▪ Metal sensitivity, or allergic reaction to a foreign body, debris, corrosion products including metallosis, staining, tumor

formation and/or autoimmune disease.

▪ Migration, loosening, or fracture of the implant.
▪ Decrease in bone density due to stress shielding.

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

WARNINGS

A successful result is not always achieved in every surgical case. Women of childbearing potential should be cautioned that
vaginal delivery of a fetus may not be advisable following SI joint fusion. If pregnancy occurs, the woman should review delivery
options with her obstetrician.

Preoperative and operating procedures, including knowledge of surgical techniques, proper selection and placement of the
implant, are important considerations in the success of surgery.

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

Proper patient selection and compliance will affect the results.
An implanted device should never be re-used, reprocessed, or resterilized under any circumstances. Sterile packaged devices

are never to be resterilized. Reuse, reprocessing, or re-sterilization may compromise the structural integrity of these implants
and create a risk of contamination of the implants which could result in patient injury, illness, or death.

PRECAUTIONS

Physician note: although the physician is the learned intermediary between the company and the patient, the important medical
information given 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

The selection of the proper implant for each patient is crucial to the 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.

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 aforementioned contraindications should be

avoided.

▪ Care should be used in the handling and storage of the implant components. The implants should not be scratched or

damaged. Implants and instruments should be protected during storage especially from corrosive environments.

▪ Since mechanical parts are involved, the surgeon should be familiar with the various components before using the

equipment and should personally verify all parts and necessary instruments are present before the surgery begins.

▪ The size of the device used for the case should be determined prior to surgery.
▪ This device is provided sterile. Additional sterile components should be available in case of an unexpected need.

INTRAOPERATIVE

▪ The instructions in any available applicable surgical technique manual should be carefully followed.
▪ At all times, extreme caution should be used.
▪ Breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel.

POSTOPERATIVE

▪ The physician's postoperative directions and warnings to the patient and the corresponding patient compliance are

extremely important.

▪ Detailed instructions on the use and limitations of the device should be given to the patient.
▪ If partial weight bearing is recommended or required prior to firm bony union, the patient must be warned that bending,

loosening, or breakage of the device are complications which can occur as a result of excessive weight bearing or muscular
activity. The risk of bending, loosening, or breakage of a device during postoperative rehabilitation may be increased if the
patient is active, or if the patient is debilitated, demented, or otherwise unable to use crutches or other weight supporting
devices. The patient should be warned to avoid falls or sudden jolts in spinal position.

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

PACKAGING

Packages for each of the implants should be intact upon receipt. Once the seal on the sterile package has been broken, the
product should not be re-sterilized. Damaged packages or products should not be used, and should be returned to Medtronic.

STERILIZATION

Devices are supplied in a sterile form. Never autoclave or in any other way attempt to re-sterilize or re-use the RIALTO™ SI
Fusion System implants.

MRI INFORMATION

The RIALTO™ SI Fusion System 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 RIALTO™ SI Fusion System in the MR
environment is unknown. Scanning a patient who has this device may result in patient injury.

PRODUCT COMPLAINTS

To report product problems, contact Medtronic.

FURTHER INFORMATION

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

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