Blackstone Spinal Fixation System 4.5MM Mono-Axial Screw

Blackstone Spinal Fixation System is intended for non-cervical use in the spine.

The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients:

a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;

b) Who are receiving fusion using autogenous bone graft only;

c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and

d) Who are having the device removed after the development of a solid fusion mass.

The Blackstone Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:

a) Degenerative spondylolisthesis with objective evidence of neurologic impairment;

b) Fracture;

c) Dislocation;

d) Scoliosis;

e) Kyphosis;

f) Spinal tumor; and

g) Failed previous fusion (pseudarthrosis).

The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle fixation, is intended for the following indications:

a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);

b) Spinal stenosis;

c) Spondylolisthesis;

d) Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);

e) Pseudarthrosis;

f) Tumor;

g) Trauma (i.e., fracture or dislocation);

h) Previous failed fusion.