Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput – T3), the Ascent POCT System is indicated for:

• Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);

• Spondylolisthesis;

• Fracture/dislocation;

• Spinal Stenosis;

• Atlanto-axial fracture with instability;

• Occipito-cervical dislocation’

• Tumors’

• Revision of previous cervical spine surgery

The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) for the treatment of thoracic conditions only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (T1-T3). The hooks are intended to be placed from C1 to T3. The Songer Cables (titanium) System to be used with the Ascent POCT System allows for wire/cable attachment to the posterior cervical spine.

The Ascent POCT System can also be linked to the Spinal Fixation System using the axial or parallel rod connector.

The Centurion POCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 – T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Centurion POCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The Centurion POCT System can also be linked to the Orthofix Spinal Fixation System using the Axial or Parallel Rod Connector.

1. When used with the Centurion POCT System or Ascent POCT System for Posterior Occipital-Cervical-Thoracic (Occ – T3) The Connector System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 – T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Connector System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

2. When used with the Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System or Spinal Fixation System (SFS) for Thoracic, Lumbar, and Sacral Spine Fixation (T1-S2/Ilium) The Connector System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Ilium), or as an anterolateral fixation system (T8-L5), in the treatment of the following acute and chronic instabilities or deformities:

1. degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)

2. spondylolisthesis,

3. trauma (i.e., fracture or dislocation),

4. spinal stenosis,

5. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),

6. tumor,

7. pseudoarthrosis, and

8. failed previous fusion

When used for posterior pedicle screw fixation in pediatric patients, the Connector System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach. The Connector System is intended to be used with autograft or allograft.

The Spinal Fixation System (SFS) is intended for non-cervical use in the spine. The Spinal Fixation System (SFS), when used for pedicle screw fixation, is intended only for patients:

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

• Who are receiving fusion using autogenous bone graft only;

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

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

The Spinal Fixation System (SFS), 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 spondylolistheses with objective evidence of neurologic impairment;

b) Fracture;

c) Dislocation;

d) Scoliosis;

e) Kyphosis;

f) Spinal tumor; and

g) Failed previous fusion (pseudarthrosis)

The Spinal Fixation System (SFS), when used for anterolateral non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:

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

b) Spondylolistheses;

c) Spinal stenosis;

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

e) Tumor;

f) Pseudoarthrosis;

g) Previous failed fusion; and

h) Trauma (i.e., fracture or dislocation)

The Firebird Spinal Fixation Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Ilium), or as an anterolateral fixation system (T8-L5), in the treatment of the following acute and chronic instabilities or deformities:

1. degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)

2. spondylolisthesis,

3. trauma (i.e., fracture or dislocation),

4. spinal stenosis,

5. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),

6. tumor,

7. pseudoarthrosis, and

8. failed previous fusion

When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.

The Firebird Spinal Fixation Systems components are used with certain components of the Spinal Fixation System (SFS), including rods, rod connectors and cross-connectors.

When used for posterior pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation Systems are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach.

The Firebird Spinal Fixation Systems are intended to be used with autograft or allograft.

The Phoenix MIS Fixation System when used with the Firebird Spinal Fixation Systems is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

The JANUS Midline Fixation Screw and the JANUS Fenestrated Screw when used with the Firebird Spinal Fixation Systems is indicated to provide the surgeon with an open, minimally invasive or midline approach for posterior spinal surgery. The JANUS Fenestrated Screws are intended to be used with saline and radiopaque dye.

The FIREBIRD SI Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacroiliac joint fusion for conditions including;

» sacroiliac joint disruptions,

* degenerative sacroiliitis,

* to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and

* Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.