XeliteMed VertehighFix High Viscosity Spinal Bone Cement System

The XeliteMed VertehighFix High Viscosity Spinal Bone Cement System is a two-component polymethylmethacrylate (PMMA) bone cement with an integrated delivery system (mixing device and hydraulic pump) for vertebroplasty and kyphoplasty procedures. It is indicated to treat pathological vertebral fractures caused by osteoporosis, benign tumors, or malignancy by injecting cement into the vertebral body to stabilize and relieve pain.

The subject device maintains identical design characteristics and materials as the predicate device. The sole technological difference is the addition of a Class I hand-operated delivery system to the previously cleared predicate device, which only consisted of the bone cement components.

ISO 11137 (sterilization); biocompatibility testing per ISO standards including cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity (acute), and material-mediated pyrogenicity.

Substantial equivalence is established because the subject device's bone cement formulation, indications for use, and intended patient population are identical to the predicate device (K241775). The addition of a Class I hand-operated delivery system does not alter the safety or effectiveness profile of the cement itself, as all prior pre-clinical testing supporting the predicate remains applicable. New testing on the delivery system (sterilization per ISO 11137 and comprehensive biocompatibility studies) demonstrates the delivery mechanism is safe and biocompatible for the intended use.