CERAMENT BONE VOID FILLER is an injectable, moldable and drillable synthetic bone void filler consisting of 40% hydroxyapatite, 60% calcium sulfate and the radio-contrast agent iohexol.
The unique ratio of hydroxyapatite and calcium sulfate is designed to enable CERAMENT to resorb at the same rate that bone forms. Calcium sulfate acts as a resorbable carrier for hydroxyapatite, and hydroxyapatite is highly osteoconductive, promoting bone ingrowth.
The characteristics of CERAMENT BONE VOID FILLER make it ideal for minimally invasive surgery and open procedures where bone remodeling is required.
Remodels into host bone within 6-12 months
With CERAMENT, simultaneous de novo bone formation is seen throughout the material and it is fully remodeled into host bone within 6-12 months. Rapid bone remodeling reduces the risk of fracture, non-union and (re)infection.
Injectable and flowable
CERAMENT can be injected through a 16G needle, making it ideal for minimally invasive procedures. Injectability is enhanced by the shape of the hydroxyapatite (HA) particles, enhancing flow and enabling injection to be performed without the need for high pressure.
Flowability ensures excellent spread into and around a bone defect. This is particularly important for complex defects, where the extent of bone loss may not be apparent at first and certain areas may be difficult to access.
Added radiopacity
Hydroxyapatite (HA) and calcium sulfate (CaS) are naturally radiopaque, but in CERAMENT BONE VOID FILLER radiopacity is enhanced by a liquid component called C-TRU®, consisting of the radiopaque agent iohexol.
This allows for the precise application of CERAMENT as it is easy to visualize under fluoroscopy.
Isothermic and not affected by room temperature
CERAMENT does not create heat during setting, so there is no risk of thermal injury to tissues.
Setting time and handling properties are consistent and reliable irrespective of the temperature of the operating room (OR).
CERAMENT is also conveniently stored at room temperature.
Easy to mix and use
The pre-filled, sterile, mixing and injection device ensures hassle-free preparation and delivery. The mixing device is simple to use and helps to achieve a homogenous paste, enhances rheology (flow characteristics) and reduces waiting time prior to application. It also reduces the risk of contamination, and there are no toxic or unpleasant fumes.
CERAMENT BVF
CERAMENT BONE VOID FILLER Mixing Chart
CERAMENT BONE VOID FILLER Product Fact Sheet
CERAMENT BONE VOID FILLER Mixing Video
Instructions for use
Request previous version of the Instructions for Use here
Patient information
Serious incidents in relation to the device should be reported to and to the TGA via www.tga.gov.au
RELATED INFORMATION
REFERENCES
REFERENCES for introduction text
CERAMENT® BONE VOID FILLER Instructions for Use.
REFERENCES for remodels into host bone within 6-12 months
Hofmann et al. ‘Autologous Iliac Bone Graft Compared with Biphasic Hydroxyapatite and Calcium Sulfate Cement for the
Treatment of Bone Defects in Tibial Plateau Fractures – A Prospective, Randomized, Open-Label, Multicenter Study.’J Bone Joint Surg Am. 2020;102:179-93.
Hettwer et al. ‘Establishment and effects of allograft and synthetic bone graft substitute treatment of a critical size metaphyseal bone defect model in the sheep femur’. APMIS 2019; 127:53–63.
Kaczmarczyk et al. ‘Complete twelve month bone remodeling with a bi-phasic injectable bone substitute in benign bone tumors: a prospective pilot study’. BMC Musculo. Dis. 2015;16:369.
REFERENCES for injectable and flowable
CERAMENT® BONE VOID FILLER Instructions for Use.
Nilsson, M. ‘Injectable calcium sulphate and calcium phosphate bone substitutes’. Lund University. 2003. ISBN: 91-628-5603-0.
Hettwer et al. ‘Establishment and effects of allograft and synthetic bone graft substitute treatment of a critical size metaphyseal bone defect model in the sheep femur’. APMIS 2019; 127:53–63.
REFERENCES for added radiopacity
CERAMENT® BONE VOID FILLER Instructions for Use.
Nilsson et al. The composite of hydroxyapatite and calcium sulphate: a review of preclinical evaluation and clinical applications. Expert Rev. Med. Devices 2013;10(5):675-684.
REFERENCES for isothermic and not affected by room temperature
S090/2007 Data on file, BONESUPPORT AB, Sweden.
S057/2010 Data on file, BONESUPPORT AB, Sweden.
CERAMENT® BONE VOID FILLER Instructions for Use.
REFERENCES for easy to mix and use
CERAMENT® BONE VOID FILLER Instructions for Use.