NanoBone Granulate - Bone matrix implant, synthetic

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Disponível em:

My Biologics Pty Ltd

Classe:

Class III

Fabricado por:

Artoss GmbH Fischerweg 421, Rostock, 18069 Germany

Área terapêutica:

17751 - Bone matrix implant, synthetic

Indicações terapêuticas:

NanoBone? Granulate is mixed with autologous patient blood and inserted as an implant into the bone defects. During the bone formation process NanoBone? will undergo degradation by osteoclasts to be completely resorbed after ~ 4 to 8 months. One characteristic feature of the biomaterial is the high porosity form of nano, micro and macro pores supporting different mechanisms of the natural ?remodeling process? of osteogenesis. Available in two granulate sizes (0.6x2.0mm and 1.0x2.0mm diameter). NanoBone? synthetic bone void filler is intended to be used for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. NanoBone? is also intended to fill, augment, and / or reconstruct maxillofacial osseous bone defects, including periodontal, oral, and craniomaxillofacial applications. NanoBone? is indicated to be placed gently into bony voids or gaps of the skeletal system, i.e., extremities, pelvis, and spine, including use in spinal fusion procedures with appropriate stabilizing hardware. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a synthetic bone void filler that resorbs and is replaced by bone during the healing process. This medical device is not intended to be used where high tensile, compressive, torsion and/or bending strength are required except when the surroundings have been properly secured mechanically with rigid fixation hardware.

Status de autorização:

A

Data de autorização:

2016-10-11