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), in the treatment of the following acute and chronic instabilities or deformities:
- Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
- Trauma (i.e., fracture or dislocation).
- Spinal stenosis.
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis).
- 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.
Contraindications include, but are not limited to:
- Morbid obesity
- Mental Illness
- Alcoholism or drug abuse
- Metal sensitivity/allergies
- Severe osteopenia
- Patients unwilling or unable to follow post-operative care instructions
- Use of the Firebird offset connectors for fixation to the ilium is contraindicated when the sacrum is absent or insufficient for implantation of pedicle screws at the S1 or S2 spinal level.
- Any circumstances not listed under the heading indications.