The Aspen 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 Aspen
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 implants with their
specifically designed instruments. After a solid fusion occurs, the
system serves no functional purpose and should be removed. Removal is
indicated because the implants are not intended to transfer or support
forces developed during normal activities. However, any decision to
remove the device must be made by the physician and the patient,
taking into consideration the patient’s general medical condition and
the potential risk to the patient of a second surgical procedure.
Indications for Use
The Biomet Spinal Fixation System (SFS) 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 Aspen device is a posterior, non-pedicle 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 Aspen 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.
Aspen device is also contraindicated in cases where the posterior
arch is missing or incomplete (e.g., laminectomy, pars defect,
Possible complications specific to the device may include:
- Early or late implant bending, breakage, failure, loosening or
- Bone and/or spinous process fracture
- Allergic reaction to implant material
Other general complications associated with any spinal surgical
procedure may include: non-union or delayed union, pseudarthrosis;
pain; second surgery; bleeding; infection, early and late; tissue or
nerve damage, including dural tears or other neurological problems;
incisional complications; scar formation; damage to blood vessels and
cardiovascular system compromise; changes in mental status; damage to
internal organs and connective tissue; complications due to the use of
bone grafting, including graft donor site complications; respiratory
problems; reactions to anesthesia and/or death.
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 Aspen 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
- 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 patient.
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.
The correct selection of the type and size of implant appropriate to
the patient and the positioning of the implant are extremely
- 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
- The Aspen device has not been tested for
safety and compatibility in the magnetic resonance (MR) environment.
The Aspen device has not been tested for heating or migration in the