Fortitude Vue features two hollow canals in the center with
texture on the caudal and cephalad surfaces. The device is crafted
from PEEK-OPTIMA® (Polyaryletheretherketone, ASTM F2026)
with Tantalum radiographic markers, and is offered in convex and
tapered styles of various sizes.
Fortitude Vue is intended to be used with the Zimmer Spine
Fortitude or Tempo® Instrumentation Systems.
Instruments are intended to assist in sizing and placement of
Fortitude Implants. The instruments can be used to measure
the height of the disc space, prepare the surgical site and insert the
The Fortitude and Tempo Instrument Systems contain
a set of trials and rasps in various heights. The trials are offered
in a tapered or convex configuration to measure the height of the
vertebral disc space.
Fortitude Vue is a vertebral body replacement device that is
intended for use in the thoracic and/or thoracolumbar spine (T3 - L5)
to replace a collapsed, damaged or unstable vertebral body resected or
excised (i.e., partial or total vertebrectomy procedures) due to tumor
or trauma (i.e., fracture). Fortitude Vue is designed to
restore the biomechanical integrity of the anterior, middle and
posterior spinal column even in the absence of fusion for a prolonged
period. Fortitude Vue is intended to be used with bone graft.
Do not use Fortitude Vue, the Fortitude
Instrumentation System, or the Tempo Instrumenation
System in the presence of any contraindication.
- Disease conditions which have been shown to be safely and
predictably managed without the use of internal fixation devices are
relative contraindications to the use of these devices.
- Active systemic infection or infection localized to the site of
the proposed implantation are contraindications to implantation.
- Severe osteoporosis is a relative contraindication because
it may prevent adequate fixation of spinal anchors and thus preclude
the use of this or any other posterior spinal instrumentation
- Any entity or condition that totally precludes the
possibility of fusion, i.e. cancer, kidney dialysis or osteopenia,
is a relative contraindication. Other relative contraindications
include obesity, pregnancy, certain degenerative disease, and
foreign body sensitivity. In addition, the patient’s occupation or
activity level or mental capacity may be relative contraindications
to this surgery. Specifically, some patients may, because of their
occupation or lifestyle, or because of conditions such as mental
illness, alcoholism or drug abuse, place undue stresses on the
- Known patient sensitivity to device materials
- When used without posterior fixation, the
device should only be used for Grade 1 or less spondylolisthesis or
Following are specific warnings, precautions, and adverse effects,
which should be understood by the surgeon and explained to the
patients. These warnings do not include all adverse effects, which can
occur with surgery in general, but are important considerations
particular to metallic internal fixation devices. General surgical
risks should be explained to the patient prior to surgery.
- THE SAFETY AND EFFECTIVENESS OF INTERBODY FUSION HAS BEEN
ESTABLISHED ONLY FOR SPINAL CONDITIONS WITH SIGNIFICANT MECHANICAL
INSTABILITY OR DEFORMITY REQUIRING FUSION WITH INSTRUMENTATION.
These conditions are significant mechanical instability secondary to
degenerative spondylolisthesis with objective evidence of neurologic
impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor
and failed previous fusion (pseudarthrosis). The safety and
effectiveness of these devices for any other conditions is unknown.
(APPLICABLE ONLY TO INDICATIONS OUTSIDE THE UNITED STATES).
- Potential risks identified with the use of this device system,
which may require additional surgery, include:
- a. Device component fracture.
- b. Loss of fixation.
- c. Non-union.
- d. Fracture of the vertebra.
- e. Neurological
- f. Vascular or visceral injury.
- CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. The
potential for satisfactory fixation is increased by the selection of
the proper size, shape and design of the implant. While proper
selection can help minimize risks, the size and shape of human bones
present limitations on the size, shape, and strength of implants.
Implants height should be determined such that adequate
decompression and stability are imparted to the instrumented
- THE NEED FOR SUPPLEMENTAL FIXATION MUST BE
DETERMINED BY THE SURGEON BASED UPON THE AMOUNT OF INSTABILITY
IMPARTED BY THE SURGERY, AS WELL AS THE PATHOLOGY ITSELF.
(APPLICABLE ONLY TO INDICATIONS OUTSIDE THE UNITED STATES).
- IMPLANTS CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING
ASSOCIATED WITH DELAYED UNION OR NON-UNION. Internal fixation
appliances are load sharing devices which are used to obtain an
alignment until normal healing occurs. If healing is delayed or does
not occur, the implant may eventually break due to fatigue. The
degree or success of union, loads produced by weight bearing, and
activity levels will, among other conditions, dictate the longevity
of the implant. Notches, scratches or bending of the implant during
the course of surgery may also contribute to early failure. Patients
should be fully informed of the risks of implant failure.
- PATIENT SELECTION. In selecting patients for internal fixation
devices, the following factors can be of extreme importance to the
eventual success of the procedure:
- The patient’s weight. An
overweight or obese patient can produce loads on the device that
can lead to a loss of interbody height or failure of the device
and/or the operation.
- The patient’s occupation or
activity. If the patient is involved in an occupation or
activity that includes substantial walking, running, lifting or
muscle strain, the resultant forces can cause loss of disc
height and/or failure of the device.
- A condition of
senility, mental illness, alcoholism, or drug abuse. These
conditions, among others, may cause the patient to ignore
certain necessary limitations and precautions in the use of the
appliance, leading to implant failure or other
- Certain degenerative diseases. In some
cases, the progression of degenerative disease may be so
advanced at the time of implantation that it may substantially
decrease the expected useful life of the appliance. For such
cases, orthopaedic devices can only be considered a delaying
technique or temporary relief.
- Foreign body
sensitivity. Where material sensitivity is suspected,
appropriate tests should be made prior to material selection or
- Smoking. Patients who smoke have been
observed to experience higher rates of pseudarthrosis following
surgical procedures where bone graft is used.
- These warnings do not include all adverse effects that can occur
with surgery in general. General surgical risks should be explained
to the patients prior to surgery.
- Do not implant any
component of the Tempo or Fortitude
Instrumentation Systems. These systems contain instruments
only, designed for use with the Fortitude implants.