Search Results

The VK100® Percutaneous Vertebral Augmentation System is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (haemangioma), or malignant lesions (metastatic cancers, myeloma).

Like the predicate devices. VK100® is provided as a two-component system with barium sulfate as a radiopacifier. VK100® is a polydimethylsiloxane material. The VK100® System consists of a cartridge containing the two VK100® material components and a dispensing system which blends the two components for injection into the injured vertebrae. The material cures in situ to form a non-resorbable polymer. The VK100® material is supplied in a pre-filled cartridge: The 2-cylinder cartridge keeps each component separate until administration, when both components are extruded through a mix element, which blends the mixture at a 1:1 ratio. Each dose (cartridge of VK100® material) consists of: - Reinforced Dimethyl Methylvinyl Siloxanes ● - . Barium Sulfate powder - Methylhydrogensiloxane Crosslinker - . Platinum catalyst, < 0.002% as metal