When used with posterior pedicle screw fixation systems in skeletally mature patients, i.e., the Firebird® Spinal Fixation System or Spinal Fixation System (SFS), the TDX Posterior Dynamic Stabilization System is intended to provide immobilization and stabilization of non-cervical spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities using autogenous graft only:
- Degenerative spondylolisthesis with objective evidence of neurologic impairment.
- Failed previous fusion (pseudoarthrosis).
When used as part of a pedicle screw implant system, the TDX Posterior Dynamic Stabilization System is intended only for grade 3 or 4 spondylolisthesis at the fifth lumbar – first sacral (L5-S1) vertebral joint.
Please refer to the Firebird® Spinal Fixation System or Spinal Fixation System (SFS) Instructions for Use (IFU) for a complete list of Indications for Use.
Note: For all indications, autogenous bone graft must be used.
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.
- If implanting the TDX Posterior Dynamic Stabilization System, any known allergy to titanium, polyurethane, or ethylene oxide residuals.
- Any circumstances not listed under the heading indications.