Medical supplies group Inion is set to strengthen its US product portfolio in spine and specialty orthopaedics after receiving 510(k) regulatory clearance from the US Food and Drug Administration (FDA) for its new Inion BioRestore™ Sahara bone filling implants for use in spinal and orthopaedic surgical procedures.
Inion BioRestore™ Sahara is a synthetic bioactive and biodegradable bone grafting substitute that can be cut or shaped precisely to fit and fill voids in bone that may result from surgery or from traumatic injury.
It is made from bioactive glass fibres and provides a highly porous scaffold onto which the patient’s new bone will grow, while gradually degrading to allow new bone to fill the void, allowing complete repair of the defect. Inion BioRestore™ Sahara can be used alone or in conjunction with Inion’s other biodegradable implants across a range of indications.
Inion BioRestore™ initially received both 510(k) clearance in the USA and CE Mark in Europe in October 2007. The new Inion BioRestore™ Sahara products now offer surgeons greater flexibility and precision for filling voids where better contact to the bone is required, as its wider porosity range allows the implant to better retain its three-dimensional space-filling structure during shaping and/or demanding implantation.