The TiTLE 2 Polyaxial Spinal System is indicated for
degenerative disc disease (defined as discogenic back pain with
degeneration of the disc confirmed by history and radiographic
studies). Levels of fixation are for the Thoracic, Lumbar and Sacral spine.
The TiTLE 2 Polyaxial Spinal System is a Pedicle Screw
System intended to provide immobilization and stabilization of spinal
segments in skeletally mature patients as an adjunct to fusion in the
treatment of the following acute and chronic instabilities or
deformities of the thoracic, lumbar, and sacral spine: degenerative
spondylolisthesis with objective evidence of neurologic impairment,
fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed
previous fusion (pseudoarthrosis).
2 Polyaxial Spinal System is also indicated for pedicle screw
fixation for severe spondylolisthesis (grades 3 and 4) at L5-S1, in
skeletally mature patients, when autogenous bone graft is used, when
affixed to the posterior lumbosacral spine, and intended to be removed
after solid fusion is attained. Levels of fixation are from L3-S1.
In addition, TiTLE 2 Polyaxial Spinal System, when not used
with pedicle screws, is indicated for hook, wire, and/or sacral screw
fixation from T1 to the ilium sacrum. The non-pedicle screw
indications are spondylolisthesis, degenerative disc disease, (defined
as discogenic back pain with degeneration of the disc confirmed by
history and radiographic studies), deformities (scoliosis, lordosis,
and kyphosis), tumor, fracture, and previous failed fusion surgery.
2 Poly Axial Spinal System can also be linked to the Minit
® Posterior Cervical and Upper Thoracic Fixation System.