Product Description
The Polaris™ Spinal System is a non-cervical spinal fixation system.
The system includes screws, various types and sizes of rods, locking
nuts, hooks, lateral connectors, plugs, washers, staples, rod
connectors/dominos and various cross connectors. Various instruments
are also available for use by the surgeon to facilitate implantation
of the device.
Indications for Use
The Polaris Spinal System is a non-cervical spinal fixation device
intended for immobilization and stabilization as an adjunct to fusion
as a pedicle screw fixation system, a posterior hook and sacral/iliac
screw fixation system, or as an anterior or anterolateral fixation
system for use with autograft and/or allograft. The Polaris Spinal
System is indicated for all the following conditions: degenerative
disc disease (defined as discogenic back pain with degeneration of the
disc confirmed by history and radiographic studies),
spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity
or curvature (i.e., scoliosis, kyphosis, Scheuermann’s disease, and/or
lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion.
The Ballista® Instruments* are intended to be used with
the Ballista/ Polaris 5.5 implants. Cannulated screws and percutaneous
rods, may be used with the Ballista instruments to provide the surgeon
with a percutaneous approach for posterior spinal surgery for the
above indications.
For pediatric patients, the Polaris Spinal System may be used for
posterior, non-cervical pedicle screw fixation as an adjunct to fusion
to treat adolescent idiopathic scoliosis and is also indicated for
treatment of the following conditions: spondylolisthesis/
spondylolysis and fractures caused by tumor and/or trauma. Pedicle
screw fixation is limited to a posterior approach.
The Polaris Spinal System may be used with the instruments in
AccuVision® Minimally Invasive Spinal Exposure System* to
provide the surgeon with a minimally invasive approach for posterior
spinal surgery.
The dominos in the Polaris Spinal System can be used to connect the
Polaris Spinal System to the Altius™ Spinal System*, the Lineum OCT
Spine System*, the Array® Spinal System*, the Omega21™
Spinal System*, or the Synergy™ Spinal System* to achieve additional
levels of fixation. Please refer to the individual system’s Package
Insert for a list of the indications for use for each system
Contraindications
- Spinal infection
- Morbid obesity
- A patient
who in the surgeon’s opinion is not psychosocially, mentally or
physically able to fully comply with the postoperative treatment
regime (e.g., mental illness, alcoholism or drug abuse.)
- Pregnancy
- Metal sensitivity/foreign body
sensitivity
- Patients with inadequate tissue coverage over
the operative site
- Open wounds local to the operative
area
- Direct current stimulation, when used in a construct
that includes Translation Screws
Warnings
- The safety and effectiveness of pedicle screw spinal systems
have been established only for spinal conditions with significant
mechanical instability or deformity requiring fusion with
instrumentation. These conditions are significant mechanical
instability or deformity of the thoracic, lumbar, and sacral spine
secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1
vertebra, 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
are unknown. Potential risks identified with the use of this device,
which may require additional surgery, include device component
fracture, loss of fixation, non-union, fracture of the vertebra,
neurological injury, and vascular or visceral injury.
- Implant Strength and Loading. The Polaris Spinal System is
intended to assist healing and is not intended to replace normal
bony structures. Loads produced by weight bearing and activity
levels will dictate the longevity of the implant. These devices are
not designed to withstand the unsupported stress of full weight
bearing or load bearing, and cannot withstand activity levels and/or
loads equal to those placed on normal healthy bone. If healing is
delayed or does not occur, the implant could eventually break due to
metal fatigue.
Therefore, it is important that immobilization
of the operative site be maintained until firm bony union (confirmed
by clinical and radiographic examination) is established. The
surgeon must be thoroughly knowledgeable in the medical, surgical,
mechanical and metallurgical aspects of the Polaris Spinal System.
Postoperative care is extremely important. The patient should be
warned that noncompliance with postoperative instructions could lead
to breakage of the implant and/or possible migration requiring
revision surgery to remove the implant. - Selection of
Implants. Selection of the proper size, shape and design of the
implant increases the potential for success. While proper selection
can help minimize risks, the size and shape of human bones present
limitations on the size and strength of implants.
- Metabolic bone disease such as severe osteoporosis may adversely
affect adequate fixation of the implants due to the poor quality of
the bone.
- The surgeon must ensure that all necessary
implants and instruments are on hand prior to surgery. They must be
handled and stored carefully, protected from damage, including from
corrosive environments. They should be carefully unpacked and
inspected for damage prior to use. All nonsterile components and
instruments must be cleaned and sterilized before use.
Zimmer
Biomet Spine implants should not be used with implants or
instruments from another manufacturer for reasons of metallurgy,
mechanics and design. - Corrosion. Contact of dissimilar
metals accelerates the corrosion process, which could increase the
possibility of fatigue fracture of the implants. Therefore, only use
like or compatible metals for implants that are in contact with each
other. Never use stainless steel and titanium implant components in
the same construct. Cobalt Chrome Alloy rods should not be used with
Stainless Steel Components.Cobalt Chrome Alloy rods are to be used
ONLY with titanium implant components in the same construct.
- The safety and effectiveness of this device has not been
established for use as part of a growing rod construct. This device
is only intended to be used when definitive fusion is being
performed at all instrumented levels.
Precautions
- Do not reuse implants/devices. While an implant/device may
appear undamaged, previous stress may have created imperfections
that would reduce the service life of the implant/device. Do not
treat patients with implants/devices that have been even momentarily
placed in or used on a different patient.
- Handling of
Implants. If contouring of the rod is required, avoid sharp bends
and reverse bends. Avoid notching or scratching of the device, which
could increase internal stresses and lead to early breakage.
- Implant Removal After Healing. After healing is complete, the
implant is intended to be removed since it is no longer necessary.
Implants that are not removed may result in complications such as
implant loosening, fracture, corrosion, migration, pain or stress
shielding of bone, particularly in young, active patients. Implant
removal should be followed by adequate postoperative
management.
- Adequate Patient Instructions. A patient must be
instructed on the limitations of the metallic implant, and should be
cautioned regarding physical activity and weight bearing or load
bearing prior to complete healing.
- Surgical Techniques.
The implantation of pedicle screw spinal systems should be performed
only by experienced spinal surgeons with specific training in the
use of pedicle screw spinal systems because this is a technically
demanding procedure presenting a risk of serious injury to the
patient. Please refer to the specific surgical technique for this
device for more information. For a copy of the surgical technique,
please contact your sales representative, or customer service at the
address provided on the cover.
- The Adjustable Length Rod
is intended for in situ adjustment after placement of the hooks or
screws during spinal fusion surgery and is intended for use as part
of either a single or double rod assembly. It allows for distraction
at a central location once bone anchors have been secured.
- The Bullet End Rods are intended for use with the Jackson
Intrasacral Fixation Technique.
Possible Adverse Effects
- Nonunion (pseudarthrosis), fibrous union (pseudoarthrosis),
delayed union or mal-union
- Loss of fixation or
malfunction, disassembly, pull-out, bending, fracture, loosening or
migration of the implant or instruments
- Metal sensitivity
or foreign body reaction to implant materials including corrosion
by-products due to use of dissimilar implant materials, possible
tumor formation, or skin or muscle sensitivity in patients with
inadequate tissue coverage over the operative site, which may result
in skin breakdown and/or wound complications
- Decrease in
bone density due to stress shielding
- Pain, discomfort, or
abnormal sensations including back/leg pain due to presence of the
implant or surgical procedure
- Nerve, soft tissue, or blood
vessel damage due to surgical trauma including loss of neurological
function, dural tears, radiculopathy, paralysis and cerebral spinal
fluid leakage
- Gastrointestinal, urological and/or
reproductive system compromise, including sterility, impotency
and/or loss of consortium
- Fracture of bony structures at,
above or below the level of surgery (fracture of the vertebra)
- Nerve root or spinal cord impingement
- Bursitis
- Necrosis of bone
- Hemorrhage of blood vessels, blood
clots, and/or hematomas
- Malalignment of anatomical
structures, including loss of proper spinal curvature, correction,
reduction and/or height
- Bone graft donor site pain
- Inability to resume activities of normal daily living
- Neurological, vascular or visceral injury
- Reoperation
- Infection/sepsis
- General surgical
complications including cardiac or respiratory issues, exposure to
radiation, thrombosis, skin irritation, wound problems, issues
related to anesthesia and/ or allergic reaction to grafting
material
- Implant malposition
- Graft
settling/displacement
- Death