The Alpine XC Adjustable MIS Fusion System is a posterior attachment
spinal fixation system composed of spinous process plates, dedicated
surgical instruments, and sterilization cases. The components are used
to build a construct to provide stabilization of spinal segments in
the thoracic, lumbar and sacral spine to support fusion. The Alpine XC
Adjustable MIS Fusion System device is part of the Biomet Spinal
Fixation System, which offers the surgeon a variety of implant
components from which to assemble a suitable construct according to
each individual patient’s needs and requirements. It is essential to
use the Biomet Spine implants with their specifically designed instruments.
Indications for Use
The Biomet Spinal Fixation System is intended to be used to help
provide immobilization and stabilization of spinal segments as an
adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The
system is intended for use with autograft or allograft. The Biomet
Spinal Fixation System is intended for posterior, non-cervical
(T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide
immobilization and stabilization of spinal segments in skeletally
mature patients as an adjunct to fusion in the treatment of the
following instabilities or deformities: degenerative disc disease
(DDD, defined as back pain of discogenic origin with degeneration of
the disc confirmed by history and radiographic studies);
spondylolisthesis; trauma (i.e. fracture or dislocation); spinal
stenosis; deformities or curvatures (i.e. scoliosis, kyphosis and/or
lordosis); tumor; pseudarthrosis; and failed previous fusion. The
Alpine XC Adjustable MIS Fusion System device is a posterior,
nonpedicle supplemental fixation device, intended for use at a single
level in the non-cervical spine (T1-S1). It is intended for plate
fixation/attachment to spinous processes for the purpose of achieving
supplemental fusion in the following conditions: degenerative disc
disease(defined as back pain of discogenic origin with degeneration of
the disc confirmed by history and radiographic studies);
spondylolisthesis; trauma (i.e., fracture or dislocation); and/or
tumor. The Alpine XC Adjustable MIS Fusion System device is intended
for use with bone graft material, not intended for stand-alone use.
Contraindications may be relative or absolute. The choice of a
particular device must be carefully weighed against the patient’s
overall evaluation. Circumstances listed below may reduce the chance
of a successful outcome. Contraindications include, but are not
- An allergy to titanium or cobalt chrome alloys, or foreign
body sensitivity. Where material sensitivity is suspected,
appropriate tests must be made prior to implantation.
or suspected infection/immune system incompetence. Acute or chronic
infectious diseases of any etiology or localization.
abnormality present which affects the normal process of bone
remodeling including, but not limited to, severe osteoporosis
involving the spine, bone absorption, osteopenia, active infection
at the site or certain metabolic disorders affecting
- Morbid Obesity. An overweight or obese patient
can produce loads on the spinal system, which can lead to failure of
the fixation of the device or failure of the device itself.
- Any neuromuscular deficit which places an unusually heavy load
on the device during the healing period.
- Open Wounds.
- Any other medical or surgical condition which
would preclude the potential benefit of spinal surgery, such as the
presence of congenital abnormalities, elevation of sedimentation
rate unexplained by other diseases, elevation of the white blood
count (WBC), or a marked left shift in the WBC differential
- Any case requiring the mixing of components from other
- Any case requiring the mixture of
stainless steel with titanium, or stainless steel with cobalt chrome
- Fever or leukocytosis.
of local infection or inflammation.
- Previous history of
- Alcoholism or heavy smoking.
mental illness or substance abuse, of a severity that the patient
may ignore certain necessary limitations and precautions in the use
of the implant, leading to failure or other complications.
- Any patient unwilling to follow postoperative instructions.
- Inadequate tissue coverage over the operative site.
Alpine XC Adjustable MIS Fusion System device is also
contraindicated for incompetent or missing posterior arch (e.g.,
laminectomy, pars defect, severe osteoporosis).
A successful result is not always achieved in every surgical case.
This fact is especially true in spinal surgery, where many extenuating
circumstances may compromise the results.
- The Alpine XC Adjustable MIS Fusion System implants are for
single use only. Never reuse any implant even if it appears unmarked
or undamaged. Reuse of the implant components may result in reduced
mechanical performance, malfunction, or failure of the device. Any
implant implanted and then removed must be discarded. Use only new
implants for each case.
- The implantation of spinal fixation
systems must only be performed by experienced spinal surgeons with
specific training in the use of this system due to the technically
demanding procedure presenting a risk of serious injury to the
- Based on the fatigue testing results, the
physician/surgeon must consider the levels of implantation, patient
weight, patient activity level, other patient conditions, etc. which
may impact on the performance of the system.
- Preoperatively: The surgeon must be fully conversant with all
aspects of the surgical technique and know the indications and
contra-indications of this type of implant. The surgeon must have
acquainted himself before the operation with the specific technique
for insertion of the product, which is available from the
manufacturer. As part of the preoperative examination, the surgeon
must check that no biological, biomechanical or other factors will
affect the correct conduct of the operation and the postoperative
period. An appropriate range of implant sizes must be available at
the time of the operation.
- Intraoperatively: The correct
selection of the type and size of implant appropriate to the patient
and the positioning of the implant are extremely important.
- Postoperatively: Patients must be informed of the precautions to
be taken in their everyday life to guarantee a maximum implant
service life. It is recommended that regular postoperative follow-up
is undertaken to detect early signs of failure of the implants and
to consider the action to be taken. Deterioration of the device
after bone consolidation cannot be considered to constitute a
dysfunction or deterioration in the characteristics of the implants.
The implant can be removed after bony healing.
- The Alpine
XC Adjustable MIS Fusion System device has not been evaluated for
safety and compatibility in the magnetic resonance (MR) environment.
The Alpine XC Adjustable MIS Fusion System device has not been
tested for heating or migration in the MR environment.