Osseoperm® Description and Indications for Use

Osseoperm® 1.0 Bone Cement Description

The Osseoperm bone cement consists of an acrylic resin and a delivery system. Osseoperm bone cement is a highly radiopaque acrylic resin of medium viscosity. The delivery system consists of an injection system that directs acrylic resin to flow into the vertebral body. The injection system consists of an injection and an extension tube. It is to be used only with needles specific for vertebroplasty with luer lock type connections.

The kit is sterile and single-use.

The injection system, the powder container and the liquid vial are contained in a hermetically sealed foil pouch pack sterilized with ethylene oxide (ETO). The liquid is sterilized by means of filtration and the powder by means of ethylene oxide treatment.

Osseoperm® 1.0 Bone Cement Indications for Use

The Osseoperm bone cement is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty procedure. Painful vertebral compression fracture may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).