Project Description

CERAFORM®

Synthetic Bone Substitute

CERAFORM® is a biocompatible and safe synthetic biphasic ceramic made of hydroxyapatite (HA) and beta tricalcium phosphate (β-TCP).

Hydroxyapatite Ca10(PO4)6(OH)2 is a calcium phosphate similar to the mineral phase of bone tissue. Tricalcium phosphate Ca3(PO4)2 , more soluble than HA, improves the resorption kinetics of CERAFORM®.

CHARACTERISTICS

  • 65% HA / 35% β-TCP
  • Pores size 150-400 µm
  • Interconnected porosity
  • Porosity: 60%-85% for granules or 35%-85% for wedges & sticks

CERAFORM® is indicated for the filling of bone defects due to bone injury (such as tumour, trauma, disease), or surgical procedure (such as arthrodesis, osteotomy).

• Granules are indicated for use in tumoral or benign bone cysts (shoulder, hip, knee, foot), fractures (shoulder, knee), osteotomies (knee), and spine fusion procedures,
• Sticks are indicated for use in fractures (knee, shoulder),
• Wedges are indicated for use in fractures (knee, shoulder).

Biphasic ceramic HA/TCP, the answer to bone defects.

SYNTHETIC
• Free from organic phase
• No immunological risk

ABSORBABLE
• Absorbed after a minimum of 2 years 1,2,3

BIOCOMPATIBLE
• Compliant to ISO 10993-1 4

1. El-Adl G, Ali AM. Does bone marrow affect the radiological outcome when added to biphasic ceramic graft in treatment of benign bone lesions? Eur J Orthop Surg Traumatol. 2013 Jan;23(1):13-20. doi:10.1007/s00590-012-0943-x. Epub 2012 Jan 22.
2. P. Botez, P. Sirbu, L. Simion, Fl. Munteanu, I. Antoniac. Application of a biphasic macroporous synthetic bone substitutes CERAFORM®: clinical and histological results. Eur J Orthop Surg Traumatol (2009) 19:387–395.
3. El-Adl G, Mostafa MF, Enan A, Ashraf M. Biphasic ceramic bone substitute mixed with autogenous bone marrow in the treatment of cavitary benign bone lesions. Acta Orthop Belg. 2009 Feb;75(1):110-8.
4. Biological Risk Assessment Report CERAFORM® 095/3/PERB

References

Designation References
CERAFORM® Granules – 3x3x3 mm – 5 cc T804402
CERAFORM® Granules – 3x3x3 mm – 10 cc T804405
CERAFORM® Granules – 3x3x3 mm – 15 cc T804407
CERAFORM® Granules – 3x3x3 mm – 20 cc T804410
CERAFORM® Granules – 3x3x3 mm – 30 cc T804415
CERAFORM® Granules – 6x6x6 mm – 15 cc T804507
CERAFORM® Granules – 6x6x6 mm – 30 cc T804515
CERAFORM® Sticks (x5) – 5x5x20 mm – 2.5 cc T807104
CERAFORM® Wedge – 8° T803008
CERAFORM® Wedge – 10° T803010
CERAFORM® Wedge – 12° T803012

Bibliography

« Aplication of a biphasic macroporous synthetic bone substitutes CERAFORM® : clinical and histological results », P. Botez, P. Sirbu, L. Simion, F. Munteanu, I. Antoniac, Eur J Orthop Surg Traumatol. (2009) 19 : 387-395
– « Biphasic ceramic bone subsitute mixed with autogenous bone marrow in the treatment of cavitary benign bone lesions », G. El-Adl, M. Mostafa, A. Enan, M. Ashraf, Acta Orthop. Belg., 2009, 75, 110-118
– « A Comparison of mineral bone graft substitutes for bone defects », D. Allison, A. Lindberg, B. Samimi, R. Mirzayan, L. Merendez, US Oncology & Hematology