OSTEOPAL® V

OSTEOPAL® V is a polymethylmethacrylate (PMMA) bone cement indicated for treating pathological vertebral fractures due to osteoporosis, cancer, or benign lesions using vertebroplasty or balloon kyphoplasty procedures. It is formed from powder and liquid through exothermic polymerization.

OSTEOPAL® V shares the same technological elements as its predicate: PMMA bone cement composition, same raw materials, biocompatibility, physical and chemical properties, mechanical performance, packaging with stability, ethylene oxide sterilization, and vertebroplasty/kyphoplasty design. Differences include cumulative sterility/shelf-life/manufacturing changes, benzoyl peroxide specification extension, addition of MR safety designation, and labeling updates.

ISO 5833 and ASTM F451 for mechanical testing; DIN EN ISO 14971 for risk-based assessment; ISO 14971 methodology for hazard evaluation.

The device operates on identical technological principles to the predicate (PMMA bone cement for vertebral fracture treatment). Risk-based assessment showed no new risks from modifications to sterility, shelf-life, manufacturing, and benzoyl peroxide specifications. Mechanical testing per ISO 5833 and ASTM F451 met initially cleared acceptance criteria. The addition of MR safety information and labeling changes do not alter the fundamental safety and effectiveness profile, as OSTEOPAL® V is non-conductive, non-metallic, and non-magnetic.