Bioactive Osteotomy Wedges Synthetic Bone Substitute
MBCP™ Wedges Synthetic Bone substitute are designed to precisely fit within the shape of the opened wedge correction. Made of MBCP™, the reference in osteoconductive synthetic bone substitute, they are a biphasic calcium phosphate made of 60% hydroxyapatite (HA) and 40% Beta-Tricalcium Phosphate (ß-TCP), allowing for simultaneous controlled adsorption and promotion of osteogenesis. While MBCP Wedges Synthetic Bone Substitute have a high compressive force of 10-12MPa, they are intended for use with rigid fixation systems.
MBCP™ Technology’s Key Features
Provides a matrix for new bone growth
HA alone resorbs too slowly while TCP resorbs too fast. Bi-phasic HA and TCP allow for a resorption rate similar to that of human bone.
Interconnected network of macropores and micropores that enables the colonization of bone cells and biological fluid uniformly within the matrix.
For ionic exchange: TCP dissolution and bone crystal precipitation. Newly bioactive interface with bone cells.
Macropores are a network of interconnected spaces that promote the biological infiltration and cellular colonization by osteoblasts and osteoclasts.
Micropores are the intercrystalline spaces where dissolution and recrystallisation occurs.
Host bone formation is systematically demonstrated.
100% synthetic – 5 years shelf life.
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4. Rouvillain, J. L., Pascal-Mousselard, H., Lavalle, F, Garron E., Catonné Y., Daculsi G., MBCP Wedges performance during open medial tibial osteotomy, European conference on biomaterials (2006) -More-
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MBCP™ must not be used for femoral or tibial osteotomies without appropriate opening osteotomy system devices, plates and screws.
Maximum contact between the product and the recipient bone must be established.
The implantation in a revision surgical site containing non-resorbable fragments of material (e.g. polyethylene ligament waste, carbon fibers) is not recommended.
As with any surgical procedure, care should be exercised in treating individuals with preexisting conditions that may affect the success of the surgical procedure. This includes (but is not limited to) individuals with long-term steroidal therapy or treatment acting on the calcium or phosphorus metabolism.
MBCP™ is radiopaque until resorbed. Radiopacity may mask underlying pathological conditions. Radiopacity may also make it difficult to radiographically assess the ingrowth of new bone.
MBCP™ is intended for use by surgeons familiar with bone grafting and rigid fixation techniques.
MBCP™ has not been tested on pregnant women. The risk of health has not been established.
- ISO 13485
- Read the instructions for use
- MBCP™ is supplied sterile and CE-marked as a Class III Medical Device according to Directive EEC/93/42
To be used in conjunction with rigid fixation system.
- High Tibial osteotomy
MBCP™ Wedges are available in: