Protected: TDX Posterior Dynamic Stabilization – International Only

​The Orthofix Spinal Implants TDX Stabilization System is a posterior dynamic rod allowing natural movements in the treated segments of the lumbar spine. Together with the company’s SFS pedicle screws, the rods can be used for single level motion preservation treatment, or as an adjunct to fusion. The TDX Stabilization System is intended to provide posterior stabilization while allowing small degrees of natural movement of the lumbar spine. As a single level treatment, the TDX rods enable movements in flexion, extension, lateral bending and rotation. Used as an adjunct to fusion, the TDX rods render dynamic stabilization while providing traditional rigid fixation in adjacent levels.

THIS DEVICE IS NOT CLEARED BY THE FDA FOR DISTRIBUTION IN THE UNITED STATES.

Product Highlights

  • Implantation through known SFS surgical technique
  • Can be used in conjunction with rigid fixation
  • Pre-assembled for reduced  insertion time
  • As a single level treatment allows for natural movement of the lumbar spine
  • Precision instruments with ergonomic handles improve tactile feel​

Indications

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:

  1. Degenerative spondylolisthesis with objective evidence of neurologic impairment.
  2. Kyphosis.
  3. 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

Contraindications include, but are not limited to:

  1. Morbid obesity.
  2. Mental Illness.
  3. Alcoholism or drug abuse.
  4. Pregnancy.
  5. Metal sensitivity/allergies.
  6. Severe osteopenia.
  7. Patients unwilling or unable to follow post-operative care instructions.
  8. If implanting the TDX Posterior Dynamic Stabilization System, any known allergy to titanium, polyurethane, or ethylene oxide residuals.
  9. Any circumstances not listed under the heading indications.