AxCess® Expandable Interbody System

The AxCess® Expandable Interbody System is a lumbar spinal fusion device designed to provide structural stability after disc removal in skeletally mature patients. It is used at one or two contiguous levels (L2–S1) to treat degenerative disc disease and must be filled with bone graft and used with supplemental spinal fixation systems such as pedicle screws or plates.

The device features an expandable design that allows adjustment to desired height and lordosis angles to match patient anatomy. It is manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and cobalt-chrome alloy (Co-28Cr-6Mo per ASTM F1537) components. It accommodates both posterior lumbar interbody fusion (PLIF) and transforaminal approaches (TLIF) and is provided sterile in multiple sizes.

Static and dynamic axial compression testing per ASTM F2077; static and dynamic compression shear testing per ASTM F2077; and subsidence testing per ASTM F2267.

The AxCess device shares nearly identical technological characteristics with its predicate devices (HALF DOME Posterior Lumbar Interbody System and FORZA XP Expandable Spacer System), including indications for use, structure and function, expandable feature, materials, sterility, and sizing. Mechanical performance testing demonstrates strength sufficient for intended use that is substantially equivalent to the predicates, with minor design differences raising no new safety or effectiveness concerns.