PMMA bone cement for vertebroplasty and kyphoplasty
SPINEFIX® and SPINEFIX® US (only sold in the US market), manufactured according to standard ISO 5833, are low viscosity, radio-opaque cements for vertebroplasty, kyphoplasty and screw augmentation*.
The high concentration of barium sulphate in this cement enables it to be used during vertebroplasty procedures. Indeed, it perfectly responds to the high level of visualisation and safety required during percutaneous vertebral augmentation procedures.
In addition, both the viscosity and setting time have been specifically developed for application in vertebroplasty: SPINEFIX® can easily be injected using a needle into the vertebral body.
The relatively long setting time for this cement gives the surgeon enough time to inject it safely into the vertebral body.
SPINEFIX® comes as an ampoule of sterile liquid and a pouch of sterile powder (liquid monomer and powder polymer).
* The pedicle screw indication is not available in the USA
- Low viscosity
- Application time 10 min
- Low exothermicity
SPINEFIX® is indicated for the fixation of pathological fractures of vertebral body using cementoplasty procedures such as vertebroplasty and kyphoplasty. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
This product is not intended to treat, cure, or prevent any cancer.
The low initial viscosity of SPINEFIX® cement make it very easy to mix and transfer in the injection system. A few minutes after beginning mixing, the cement reaches a viscosity level convenient for vertebral augmentation procedures.
The viscosity has been specifically developed for application in vertebroplasty: SPINEFIX® can be injected easily, using an injection kit and a G11 or 10 needle, into the vertebral body, while avoiding cement leakages outside the vertebral body.
From the start of mixing, the operator has 12 minutes to apply the cement to the vertebral body. This is more than sufficient to conduct continues radiological checks and perform a several filling operations over a periode of time, thereby avoiding any undesirable migration of the cement.
The mechanical properties of SPINEFIX® cement are better than standard ISO 5833.
|Kit MINI MALAX ®||T060406|
|Kit S5 ®||T060410|
|EASY KIT ®||T060409|
|TROCAR TEKNIMED||T060406 – T060431 – T060432T060433 – T060434 – T060435|
|SPINEFIX® – SPINEFIX® US||T040320S – US040320S|
Classe : IIb
SpineFix® US: The device is only cleared to be sold in US market