Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

my biologics pty ltd - 17751 - bone matrix implant, synthetic - nanobone? block will be fixed with bone screws as an implant into the bone defects. during the bone formation process nanobone? will undergo degradation by osteoclasts (macrophages) to be completely resorbed after approx. 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. 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.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

my biologics pty ltd - 17751 - bone matrix implant, synthetic - 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.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

device technologies australia pty ltd - 17751 - bone matrix implant, synthetic - the device is an osteoconductive bioactive device used for grafting osseous defects. it is a pre-mixed composite of bioactive calcium-phospho-silicate particulate and a synthetic, absorbable binder and composed solely of elements that exist naturally in normal bone. a series of surface reactions results in the formation of a calcium phosphate layer on the particles which provides scaffolding onto which new bone will grow allowing complete repair of the defect. a bioactive synthetic bone matrix implant intended to be packed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. these defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. the device provides a bone filler that resorbs and is replaced with bone during the healing process.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

device technologies australia pty ltd - 17751 - bone matrix implant, synthetic - the device is an osteoconductive bioactive device used for grafting osseous defects. it is a pre-mixed composite of bioactive calcium-phospho-silicate particulate and a synthetic, absorbable binder and composed solely of elements that exist naturally in normal bone. a series of surface reactions results in the formation of a calcium phosphate layer on the particles which provides scaffolding onto which new bone will grow allowing complete repair of the defect. a bioactive synthetic bone matrix implant intended to be packed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. these defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. the device provides a bone filler that resorbs and is replaced with bone during the healing process.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

device technologies australia pty ltd - 17751 - bone matrix implant, synthetic - the device is an osteoconductive bioactive device used for grafting osseous defects. it is a pre-mixed composite of bioactive calcium-phospho-silicate particulate and a synthetic, absorbable binder and composed solely of elements that exist naturally in normal bone. a series of surface reactions results in the formation of a calcium phosphate layer on the particles which provides scaffolding onto which new bone will grow allowing complete repair of the defect. a bioactive synthetic bone matrix implant intended to be packed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. these defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. the device provides a bone filler that resorbs and is replaced with bone during the healing process.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

device technologies australia pty ltd - 17751 - bone matrix implant, synthetic - the device is an osteoconductive bioactive device used for grafting osseous defects. it is a pre-mixed composite of bioactive calcium-phospho-silicate particulate and a synthetic, absorbable binder and composed solely of elements that exist naturally in normal bone. a series of surface reactions results in the formation of a calcium phosphate layer on the particles which provides scaffolding onto which new bone will grow allowing complete repair of the defect. a bioactive synthetic bone matrix implant intended to be packed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. these defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. the device provides a bone filler that resorbs and is replaced with bone during the healing process.

Singapur - anglès - HSA (Health Sciences Authority)

scient'x asia pacific pte. ltd. - orthopaedics - intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. it is intended to provide stabilization during the development of fusion utilizing a bone graft.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

nuvasive (aust/nz) pty ltd - 17751 - bone matrix implant, synthetic - attrax putty bone void filler consists of beta tcp and hydroxyapatite in a putty form. it induces and guides the three-dimensional regeneration of bone in the defect site into which it is implanted. when placed next to viable host bone, new bone will be deposited on the surface of attrax. it then resorbs and is replaced by bone during the natural process of bone remodelling. attrax putty bone void filler is intended for use as bone void filler for voids and gaps that are not intrinsic to the stability of the bony structure. attrax is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. attrax is intended to be packed into bony voids or gaps of the skeletal system (i.e., extremities, spine, and pelvis) and may be combined with autogenous bone, blood, prp, and/or bone marrow. attrax should not be used to treat large defects that in the surgeon?s opinion would fail to heal spontaneously. in load bearing situations, attrax is to b

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 17751 - bone matrix implant, synthetic - used to fill defects that may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. it is a bone graft substitute that resorbs and is replaced with bone during the healing process. indicated for filling bone voids or defects of the skeletal system (such as the extremities, spine, and the pelvis) that are not intrinsic to the stability of the bony structure.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

prism surgical designs pty ltd - 17751 - bone matrix implant, synthetic - non structural bioactive synthetic bone graft substitute that is resorbable composed of biphasic calcium phosphate microgranules( 60%hydroxyapatite/40% beta -tricalcium phosphate) and a viscoelastic polymer. it acts as a bone void filler and has a micro- macroporous structure with 70% porosity that acts as scaffold for new bone tissue growth in addition to release of ions into target area. supplied in a malleable form to perfectly fit with bone defect shape loaded in a syringe applicator. in?oss? is intended for use as bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. these defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. when packed into a bony site, in?oss? gradually resorbs and is replaced with bone during the healing process.