Project Description

F20®

PMMA bone cement for vertebroplasty and kyphoplasty

F20 ® cement, manufactured in accordance with standard ISO 5833, is a medium viscosity, ready-to-use cement containing a high concentration of radio-opaque agent, making it highly visible and therefore safe to use, both essential parameters during a percutaneous vertebroplasty/kyphoplasty procedure. The chemical composition has been optimized to get the must suitable handling properties for pratician’s convenience.

F20 ® comes as an ampoule of sterile liquid and a pouch of sterile powder (liquid monomer and powder polymer).

ADVANTAGES

  • High radio-opacity
  • Medium viscosity
  • Biocompatibility
  • Easy to handle
  • Long working time

F20 ® is indicated for the fixation of pathological fractures of vertebral body ( 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.

Hardening

The low polymerisation temperature of F20 ® makes it the less exothermic bone cement on the market.

 

Rheology

Its low initial viscosity makes it very easy to mix the powder and liquid components. Immediately after mixing, the cement stabilises at a medium viscosity level, ideally suited to a vertebroplasty/kyphoplasty procedure. The waiting time is not so long.

The medium viscosity of F20 ® cement has been optimised to reduce leakages and enable an homogenous filling of the vertebra.

At 20°C, F20 ® cement can be injected for up to 20 minutes with the recommended Teknimed S5-M injection kit, making it possible to perform multiple injections comfortably with a single dose of cement.

 

Mechanical properties

The mechanical properties of F20 ® cement are superior to standard ISO 5833

Description Reference
Kit S5 M  S5M purple: T060407 – S5M white: T060423
EASY KIT® M  T060415
TROCAR TEKNIMED T060406 – T060431 – T060432T060433 – T060434 – T060435

References

Description Reference
F20 ®  T040520

Certifications

CE 2797
The device is cleared to be sold in US market.
Class: IIb

Bibliography

Anselmetti, G. C., A. Manca, et al. (2009). « Temperature measurement during polymerization of bone cement in percutaneous vertebroplasty: an in vivo study in humans. » Cardiovasc Intervent Radiol 32(3): 491-8.
Anselmetti, G. C., G. Corrao, et al. (2007). « Pain relief following percutaneous vertebroplasty: results of a series of 283 consecutive patients treated in a single institution. » Cardiovasc Intervent Radiol 30(3): 441-7.
Muijs, S. P., M. J. Nieuwenhuijse, et al. (2009). « Percutaneous vertebroplasty for the treatment of osteoporotic vertebral compression fractures: evaluation after 36 months. » J Bone Joint Surg Br 91(3): 379-84.
Afzal, S., S. Dhar, et al. (2007). « Percutaneous vertebroplasty for osteoporotic fractures. » Pain Physician 10(4): 559-63.