Osseoperm Bone Cement
Osseoperm is a viscous polymethyl methacrylate (PMMA) bone cement, designed for vertebral augmentation, vertebroplasty and kyphoplasty. The Osseoperm system offers a simple mixing technique, excellent working characteristics, and a clutch handle cement delivery device for flow control.
Osseoperm system includes:
- Bone Cement
- one 20g container of polymer powder
- one 9.4g vial of monomer
- 12cc of mixed cement
- medium viscosity
- setting time from start of mixing:
- 23 minutes at 64oF/18oC
- 17 minutes at 70oF/21oC
- 12 minutes at 77oF/25oC
- 30% barium sulfate to permit fluoroscopic visualization
- Mixing Container
- monomer is added to polymer container and hand-shaken to mix cement
- Delivery System
- transparent 12cc cement syringe
- extension tubing with Luer-Lok® connectors
Osseoperm bone cement:
Osseoperm bone cement achieves medium viscosity within minutes after mixing. Mixed in the polymer container by adding monomer and shaking vigorously for 60 seconds.
Osseoperm delivery system:
The Osseoperm clutch control injector system is engineered to allow complete control over the flow of cement at any time during delivery.
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 fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Refer to the IFU for additional information.
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 injector 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 are contained in a hermetically sealed blister pack sterilized with ethylene oxide. The liquid is sterilized by means of filtration and the powder by means of ethylene oxide treatment.