IMPORTANT SAFETY INFORMATION Sacroiliac Joint Fusion

Summary of Important Product 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.

Please contact Customer Service or your Sales Representative for the most up-to-date revision of the package insert for current indications, warnings, precautions and other important medical information.