Project Description

F20®

Pasty Bone Cement for vertebroplasty & kyphoplasty

F20® radiopaque bone cement is a ready to use, medium viscosity, low exothermic, self-curing bone cement with a high content of radiopaque agent for a perfect level of visualization and safety required during percutaneous vertebral bone augmentation procedures.

Its composition has been optimized to get the most suitable handling properties for surgeon’s convenience.

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

ADVANTAGES

  • Synthetic
  • High radio-opacity
  • Medium viscosity
  • Biocompatibility
  • Easy & safe injection
  • Long working time

The F20 is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures.

Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

PHYSICO-CHEMICAL COMPOSITION
Bone cement with two components. PMMA bone cement made of powder polymer and liquid monomer.

SYNTHETIC & BIOCOMPATIBLE
Free from organic phase and no adverse reaction observed.

EASILY INJECTABLE
The long working time of 22 minutes allows to perform a multi level injection procedure.

VISCOSITY
The medium viscosity of F20® is ideal to permit an homogeneous bone filling and prevents leakages.

RADIO-OPACITY
F20® has an excellent radio-opacity due to a high rate of opacifier for an ideal and maximum visibility during injection.

LOW EXOTHERMICITY (less than 45°C)
F20® prevents necrosis of bone tissues by an extraordinary low exotermicity reaction close to 45°c which is much lower than other vertobroplasty bone cements.

Description Reference
Kit MEDV + T060417
Kit S5 M  S5M purple: T060407 – S5M white: T060423
EASY KIT® M  T060415
TROCAR TEKNIMED T060430 – T060431 –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.