Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 46425 - bone matrix implant, animal-derived, bioabsorbable - mastergraft? matrix are made from a combination of medical grade purified collagen and biphasic calcium phosphate ceramic. the collagen is a highly purified type i bioresorbable lyophilized collagen. mastergraft? matrix are supplied sterile in a premixed strip form for single patient use. mastergraft? products are biocompatible, osteoconductive, porous implants that allows for bony in growth across the graft site while resorbing at a rate consistent with bone healing. mastergraft? matrix is intended to help fill voids or gaps in bone, which may be surgically created osseous defects, or osseous defects caused by traumatic injury to the bone. mastergraft? matrix provides a bone void filler that is resorbed and is replaced with bone during the natural healing process.

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 46425 - bone matrix implant, animal-derived, bioabsorbable - mastergraft? strips are made from a combination of medical grade purified collagen and biphasic calcium phosphate ceramic. the collagen is a highly purified type i bioresorbable lyophilized collagen. mastergraft? strips are supplied sterile in a premixed strip form for single patient use. mastergraft? products are biocompatible, osteoconductive, porous implants that allows for bony in growth across the graft site while resorbing at a rate consistent with bone healing. mastergraft? strips is intended to help fill voids or gaps in bone, which may be surgically created osseous defects, or osseous defects caused by traumatic injury to the bone. mastergraft? strips provides a bone void filler that is resorbed and is replaced with bone during the natural healing process.

Australia - English - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 17751 - bone matrix implant, synthetic - consists of an implant kit containing 1 vial powder (calcium sulfate) and 1 vial of sterile water; and a mixing and delivery kit containing a syringe & cap, 2 needles, 1 spatula and one vacuum mixing bowl. total injection time ~2.5 min, set time ~11 min. to be injected into open bone voids/gaps that are not intrinsic to the stability of bony structure in the skeletal system (i.e., the extremities, spine, and pelvis) and to cure in-situ. the open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. the miig paste provides a bone void filler that resorbs and is replaced with bone during the healing process. the miig paste cured in-situ provides an open void/gap filler that can augment provisonal hardware (e.g., k-wires) to help support bone fragments during the surgical procedure. the cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

Australia - English - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 17751 - bone matrix implant, synthetic - preformed calcium sulfate / calcium phosphate pellets provided in glass vials that are gently packed into open bone voids/gaps. the pellets provide a bone void filler that resorbs and is replaced with bone during the healing process. for use as a bone void filler to be gently packed into open bone voids/gaps that are not intrinsic to the stability of bony structures of the skeletal system (i.e., the extremities, spine, and pelvis). these open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. the pellets provide a bone void filler that resorbs and is replaced with bone during the healing process.

Australia - English - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 17751 - bone matrix implant, synthetic - the pro-dense core decmpression procedure kit, consisting of bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. the bone void filler component resorbs and is replaced with bone during the healing process. for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities, spine,and pelvis) to cure in-situ. these open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. the paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process. provides an open void/gap filler that can augment provisional hardware (e.g k-wires) to help support the bone fragments during the surgical procedure. to act only as a temporary support media and is not intended to provide structural support during the healing process. the kit is intend

Australia - English - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 17751 - bone matrix implant, synthetic - calcium salt cement formulation consisting of a powder component and an aqueous mixing solution. when the two components are mixed according to the directions, an injectable paste is formed which is injected into the implant site to cure in situ. consists of a kit containing implant material calcium sulphate/calcium phosphate, an instrument kit consisting of syringe/s and needles, implant kit consisting of 1 powder container, 1 vial of mixing solution, 1 mixer and accessories. for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities, spine, and pelvis) to cure in-situ. these open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. the paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process. the paste cured in-situ provides an open void/gap filler that can aug

Australia - English - Department of Health (Therapeutic Goods Administration)

health care surgical - 17751 - bone matrix implant, synthetic - mbcp? is a bone graft substitute. mbcp? is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% hydroxyapatite (ha) and 40% beta-tricalcium phosphate (?-tcp). mbcp? may be used with physiological saline, patient?s own serum, whole blood, or bone marrow aspirate (bma). mbcp is intended for use as a bone void filler for bony voids or gaps of the skeletal system. it is used in the extremeties, spine and pelvis that is not intrinsic to the stability of the bony structure. mbcp can be used with autograft as a bone graft extender. these defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. when packed into a bony site, mbcp gradually reabsorbs and is replaced with bone during the healing process.

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 46425 - bone matrix implant, animal-derived, bioabsorbable - mastergraft? matrix ext is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. in the devices, the collagen is a highly purified (>95%) type i bioresorbable lyophilized collagen. the biphasic ceramic portion of the device is provided in a 15 percent hydroxyapatite and 85 percent ?-tricalcium phosphate formulation. mastergraft? matrix ext is supplied sterile in a premixed strip form for single patient use. mastergraft? matrix ext is to be combined with autogenous bone marrow and is indicated for bony voids or gaps not intrinsic to the stability of the bony structure and can be used as a bone graft extender. the device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, pelvis, ilium,and/or extremities). these defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. the device resorbs and is replaced with bone during the healing process.

Australia - English - Department of Health (Therapeutic Goods Administration)

signature orthopaedics pty ltd - 17751 - bone matrix implant, synthetic - the device is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% hydroxyapatite (ha) and 40% beta-tricalcium phosphate (?-tcp). when packed into a bony site, the device gradually resorbs and is replaced with bone during the healing process. the device is intended for use as a 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. the device can be used with autograft as a bone graft extender. these defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Australia - English - Department of Health (Therapeutic Goods Administration)

arthrex australia pty ltd - 17751 - bone matrix implant, synthetic - arthrex quickset device is an injectable self-hardening macroporous calcium phosphate bone void filler. the procedure pack includes arthrex quickset and a sterile cannula which is connected to the syringe tip and used to direct the quickset into the appropriate site. arthrex quickset is intended for filling or reinforcing bony voids or defects 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. these products provide a bone void filler that resorbs and is replaced with bone during the healing process.