TriCor™ Sacroiliac Joint Fusion System

The TriCor Sacroiliac Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The TriCor Sacroiliac Joint Fusion System is manufactured from Titanium alloy in accordance with ASTM F136 as well as an optional version where exterior surfaces are coated with medical-grade commercially pure titanium (CP Ti) per ASTM F1580. All implants are intended as single use only and should not be reused under any circumstances.

The TriCor Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroilitis.

Contraindications for the TriCor Sacroiliac Joint Fusion System are similar to those of other systems of similar design, and include, but are not limited to:

1. Patients with probable intolerance to the materials used in the manufacture of this device.
2. Patients with infection, inflammation, fever, tumors, elevated white blood count, obesity, pregnancy, mental illness and other medical conditions which would prohibit beneficial surgical outcome.
3. Patients resistant to following post-operative restrictions on movement, especially in athletic and occupational activities.
4. Use with components from other systems.
5. Grossly distorted anatomy caused by congenital abnormalities.
6. Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery.
7. Rapid joint disease, bone absorption, osteopenia. Osteoporosis is a relative contraindication since this condition may limit the degree of obtainable correction, stabilization, and/or the amount of mechanical fixation.
8. Any case where the implant components selected for use would be too large or too small to achieve a successful result.
9. Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
10. Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance.
11. Any case not described in the indications for use.
12. Reuse or multiple uses.

1. System instruments are provided non-sterile and must be sterilized before use. Validated sterilization cycle parameter protocols are noted in the STERILIZATION section of this insert.
2. As with all orthopedic and neurosurgical implants, none of the system implants should ever be reused under any circumstances. Risks associated with reuse include infection, non-union (pseudarthrosis), serious patient injury or death.
3. The TriCor Sacroiliac Joint Fusion System has not been evaluated for safety and compatibility in the MR environment. The TriCor Sacroiliac Joint Fusion System has not been tested for heating or migration in the MR environment. The safety of the TriCor Sacroiliac Joint Fusion System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

As with any surgical system, the TriCor Sacroiliac Joint Fusion System should be used by experienced surgeons with specific training in the use of the spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.

Knowledge of surgical techniques, proper reduction, selection and placement of implants, and pre- and post-operative patient management are considerations essential to a successful surgical outcome. Appropriate selection, placement and fixation of the spinal system components are critical factors which affect implant service life. As in the case of all prosthetic implants, the durability of these components is affected by numerous biologic, biomechanics and other extrinsic factors, which limit their service life. Accordingly, strict adherence to the indications, contraindications, precautions, and warnings for this product is essential to potentially maximize service life. (Note: While proper implant selection can minimize risks, the size and shape of human bones present limitations on the size, shape, and strength of the implants).

Patients who smoke have been shown to have an increased incidence of pseudoarthrosis. Such patients should be advised of this fact and warned of the potential consequences. Patients with previous spinal surgery at the level to be treated may have different clinical outcomes compared to those without a previous surgery. Based on the fatigue testing results, the physician/surgeon should consider the level of implantation, patient weight, patient activity level, and other patient conditions, etc. which may have an impact on the performance of the system. For women of childbearing potential: If pregnancy occurs, the woman should review delivery options with her obstetrician. Vaginal delivery of a fetus may not be advisable following SI joint fusion.

If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.g. substantial walking, running, lifting, or muscle strain) resultant forces can cause failure of the device. In some cases, progression of degenerative disease may be so advanced at the time of implantation that theexpected useful life of the appliance may be substantially decreased. In such cases, orthopedic devices may be considered only as a delaying technique or to provide temporary relief. Patients should be instructed in detail about the limitations of the implants, including, but not limited to, the impact of excessive loading through patient weight or activity, and be taught to govern their activities accordingly. The patient should understand that a metallic implant is not as strong as normal, healthy bone and will bend, loosen or fracture if excessive demands are placed on it. An active, debilitated, or demented patient who cannot properly use weight supporting devices may be particularly at risk during postoperative rehabilitation.

Care must be taken to protect the components from being marred, nicked or notched as a result of contact with metal or abrasive objects. Alterations will produce defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant.