?-TCP Granules (GranOS) - Bone matrix implant, synthetic

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Disponível em:

Pureplay Orthopaedics

Classe:

Class III

Fabricado por:

TCM Associates Limited 3 Hillgrove Business Park Nazeing Road, Nazeing, Essex, EN9 2HB United Kingdom

Área terapêutica:

17751 - Bone matrix implant, synthetic

Indicações terapêuticas:

GranOS granules (constructed of ?-tri-calcium phosphate) create a porous, resorbable osteoconductive scaffold, that facilitates new bone growth upon which new bone deposits and matures. Interconnected pores within the granules, support revascularisation and cellular invasion as the regenerating bone is guided throughout the defect. Bone forming cells are infused, enhancing the processes of new bone development and the eventual resorption of the scaffold, as the healing process progresses. GranOS is intended to be used as a synthetic bone void filler. It is only indicated for filling and/or augmenting bony voids or gaps that are not intrinsic to the stability of the bone structure i.e. subjected to either low load or compressive loading. If osseous defects are intrinsic to the stability and integrity of the skeleton, mechanical stability must be addressed prior to use.

Status de autorização:

A

Data de autorização:

2015-02-12