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

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

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 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.