Product Description
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 Zimmer 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 Zimmer Biomet Spine implants with
their specifically designed instruments.
Indications for Use: United States
The Zimmer 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 Zimmer 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.
Indications for Use: Outside the United States
The
Alpine XC system is a spinous process fixation device intended to
provide stabilisation in the thoracic, lumbar and sacral spine
(T1-S1). It can be used as an adjunct to interbody and/or
posterior fusion or as a standalone fixation device.
The
Alpine XC system is indicated in the treatment of the following
conditions: degenerative disc disease; spinal stenosis;
spondylolisthesis; trauma (e.g. fractures, dislocation); spinal
deformities (scoliosis, kyphosis, lordosis); spinal tumours;
pseudoarthrosis or failed previous fusion surgery; and/or spinal
instability.
The Alpine XC system can be used in single- or
multi-level constructs. It can be used alone or in combination
with other spinal devices (e.g. pedicle screws, facet screws,
anterior plates or interbody cages). The Alpine XC system can be
used with or without bone grafting.
Contraindications
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 limited to: