VCFix Spinal System

The VCFix Spinal System is a cannulated, screw-shaped titanium implant with an expandable plate structure used to treat vertebral compression fractures from osteoporosis, trauma, or malignant lesions in the thoracic and lumbar spine (T9–L5). A pair of implants are inserted through the pedicles via a minimally invasive approach, expanded to restore vertebral height, and then stabilized with injected PMMA bone cement (Teknimed F20).

The VCFix is a titanium alloy (Ti-6Al-4V) cannulated implant available in 7 sizes (5–6.5 mm insertion diameter, 41–51.2 mm length) with perforated expansion plates and a jack mechanism for cranio-caudal expansion. It differs from the SpineJack predicate mainly in geometric details (perforated versus cut-through features) and implant sizing, but operates on the same principles of bilateral transpedicular insertion, in-situ expansion, and cement fixation with optional posterior instrumentation.

ASTM F2077 (static and dynamic compression and shear), ASTM F2193 (static torsion and screw driving torque), ISO 10093-1 (biological safety evaluation), lift force testing, functionality testing with cement, magnetic resonance safety testing, and packaging, sterility, and shelf-life validation.

The VCFix and SpineJack predicate share identical indications for use, target population, anatomical site, surgical approach, and operational principle (minimally invasive transpedicular insertion, in-situ expansion, cement fixation). Although the VCFix has minor geometric differences (perforated plates, 7 versus 3 sizes), these features fall within the dimensional range of previously cleared devices and are supported by equivalent mechanical and functional testing. No new safety or effectiveness risks are raised by these design variations, making the systems substantially equivalent in their fundamental technology and performance for treating thoracolumbar compression fractures.