VADER® Pedicle System and VADER®one Pedicle System

The VADER® Pedicle System and VADER®one Pedicle System are posterior pedicle screw fixation systems made from Carbon/PEEK used to restore spinal column integrity in patients with advanced tumors of the thoracic and lumbar spine with limited life expectancy, and to stabilize the spine as an adjunct to fusion in patients with spinal infection. The systems comprise polyaxial cannulated pedicle screws (fenestrated and non-fenestrated), curved and straight rods, and connectors for single or multiple level fixations in the non-cervical spine.

The devices are manufactured from Carbon/PEEK using a proprietary manufacturing process and include polyaxial cannulated pedicle screws (both fenestrated and non-fenestrated variants), curved, straight, S-rods, J-rods, and connector components. When used with specific bone cements and mixing/injection systems, fenestrated screws can be augmented with G21 V-Fast or V-Steady Bone Cement for tumor cases where structural integrity is not severely compromised.

Bench testing per ASTM F1798 (static axial gripping capacity and static torque gripping capacity testing) and ASTM F1717 (dynamic compression bending).

The subject device demonstrates substantial equivalence through identical indications for use (tumor stabilization and infection-related instability), identical design principles and materials (Carbon/PEEK pedicle screw systems with polyaxial cannulated screws and rod-connector constructs), and equivalent manufacturing and functional characteristics to the primary predicate VADER® Pedicle System (K232628). Performance testing shows the device meets the same mechanical standards as predicates, and no changes to design, materials, function, or intended use would create new safety or effectiveness concerns relative to legally marketed predicate devices.