Innovative Spinal Facet Replacement System

A new orthopedic facet replacement system treating spinal stenosis replaces degenerative facet joints with a prosthetic joint implant intended to restore stability and normal motion to the spine, eliminating the need for fusion.

The Archus Total Facet Arthroplasty System (TFAS)-C system is indicated for the L3-4 and L4-5 spinal levels, and it complements the company's TFAS-LS system, which addresses the unique anatomy of the L5-S1, the lumbosacral spinal level. Both systems are part of TFAS, 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-C is fixed within the pedicles and it 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. The system 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 preoperative imaging measurements and intraoperative trialing. Pedicle fixation of TFAS components is accomplished via the use of polymethylmethacrylate (PMMA) containing 30% barium sulphate. A specialized set of instruments facilitates implantation of the TFAS components. The TFAS modules, developed by Archus Orthopedics (Redmond, WA, USA), have been successfully implanted in nearly two hundred patients worldwide, with the vast majority treated in the United States in an ongoing investigational device exemption (IDE) study approved by the U.S. Food and Drug Administration (FDA).

”The TFAS-C completes our spinal stenosis product line and it is gratifying to see all three devices now in clinical use,” said Jim Fitzsimmons, chairman and CEO of Archus Orthopedics. "We expect to complete marketing trials this year and plan to pursue a broad but controlled launch in Europe next year.”

"The full product line that Archus has developed for spinal stenosis allows me to treat almost all comers and gives me multiple device options to address variable patient anatomy and pathology,” added Scott Webb, M.D., a spine surgeon at the Florida Spine Institute (Clearwater, USA) who performed the first TFAS implantation in 2005, which was one of the earliest facet joint replacement procedures ever completed.


Related Links:
Archus Orthopedics
Florida Spine Institute