Total Facet Arthroplasty System (TFAS™): Clinical Trial Device Description

TFAS™ is an articulating joint prostheses intended to restore normal motion and provide stabilization of spinal segments in skeletally mature patients. It can be used as an adjunct to laminectomy, laminotomy, neural decompression and facetectomy, in lieu of fusion, for treatment of instabilities or deformities of the lumbar spine including:

• Degenerative disease of the facets;
  
• Degenerative disease of the facets with instability;
  
• Grade 1 degenerative spondylolisthesis with objective evidence of neurologic impairment;
  
• Central or lateral spinal stenosis.

The Total Facet Arthroplasty System™ (TFAS™) is a modular implantable device that is intended to replace the facets and excised elements of the posterior lumbar spine following facetectomy and neural decompressive procedures. Implanted via an open posterior surgical approach, TFAS™ is fixed within the pedicles and provides immediate alignment and stabilization of the spinal segment at a single spinal level, L3-L4 or L4-L5, while maintaining anatomical ranges of motion.

TFAS™ is comprised of implantable grade metal components offered in a range of sizes to address the specific anatomical requirements of each patient. Implant component selection is made based upon pre-operative imaging measurements and intra-operative trialing. Pedicle fixation of TFAS™ components is accomplished via the use of polymethylmethacrylate (PMMA) cement. Archus Bone Cement, containing 30% barium sulphate, is the only cement validated for use as a component of the TFAS™ system. A specialized set of instruments facilitate implantation of the TFAS™ components.

Questions? Please email Archus Orthopaedics.

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• Treating Low Back Pain with Passive Modalities