Xenco Medical CancelleX Cervical Interbody System

The Xenco Medical CancelleX Cervical Interbody System is a titanium spinal fusion device used to treat degenerative disc disease in the cervical spine (C3-C7 levels). It is implanted via anterior surgical approach and packed with the patient's own bone, used alongside supplemental fixation systems, in patients who have completed at least six weeks of non-operative treatment.

The device is a box-shaped titanium implant (TI-6AL-4V) with surface teeth, a central channel for bone packing, and anterior holes for instrument mating. Key innovation is 3D printing from titanium, which enables incorporation of porous latticed areas equivalent to the additional predicate device (K222015). The device includes anti-migration features (linear rows on superior and inferior surfaces) and is available in multiple sizes and geometries matching the primary predicate.

ASTM F2077 (static and dynamic axial compression, compression shear, and torsion testing); ASTM F2267 (subsidence testing); laboratory protocol for expulsion testing. Testing aligned with FDA Class II Special Controls Guidance for Intervertebral Body Fusion Devices.

The subject device has identical intended use and indications as the primary predicate (K140786). Although 3D-printed titanium manufacturing differs from the predicate's traditional approach, the resulting geometry, sizing, and functionality are equivalent. The porous lattice features match the additional predicate (K222015), which is also 3D-printed titanium. Non-clinical mechanical testing demonstrates equivalent or superior strength across compression, shear, torsion, subsidence, and expulsion parameters, establishing that the device performs as well as legally marketed predicates despite the manufacturing innovation.