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

orthopediatrics aus pty ltd - 44854 - fixation nail, intramedullary, arthrodesis - the gap endo-exo medullary system is indicated as a temporary implant to assure alignment, stabilization and fixation of: long bones that have been surgically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. the gap system is used for pediatric patients (child and adolescent) ages 2 to 21. it can be used to correct the following conditions: ? diaphyseal facture of the femur, tibia and humerus ? fractures of the femoral neck ? subtrochanteric, intertrochanteric and combination fractures ? correction of deformities (oi, coxa vara, coxa valga) ? nonunions and malunions

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

orthopediatrics aus pty ltd - 37272 - fixation device, internal, spine, construct - intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures, including: spinal trauma surgery, used in sublaminar, or facet wiring techniques; spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis; spinal degenerative surgery, as an adjunct to spinal fusions. used in conjunction with other medical implants made of titanium alloy or cocr alloy whenever "wiring" may help secure the attachment of other implants.

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

orthopediatrics aus pty ltd - 35714 - casting stand, orthopaedic - a base or pedestal that supports an appendage during a casting procedure.

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

orthopediatrics aus pty ltd - 37272 - fixation device, internal, spine, construct - for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumour, pseudarthrosis, and/or failed previous fusion. when used for posterior non-cervical pedicle screw fixation in paediatric patients, the implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. intended to be used with auto graft and/or allograft. paediatric pedicle screw fixation is limited to a posterior approach.

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

orthopediatrics aus pty ltd - 44054 - surgical procedure kit, orthopaedic, reusable - a collection of various surgical instruments used to perform an orthopaedic surgical procedure. this is a reusable device.

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

orthopediatrics aus pty ltd - 32854 - orthopaedic bone pin, non-bioabsorbable - intended for external fixation with the following indications: 1. stabilisation of fractures & osteotomy 2. rear & mid-foot foot arthrodesis 3. adult and pediatric leg lengthening 4. correction of bone deformity in upper & lower extremities

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

orthopediatrics aus pty ltd - 48011 - orthopaedic external fixation system, single-use, non-sterile - the orthex external fixation system consists of a series of circular external fixators and accessories. these devices are intended as a means to stabilize bone segments in a broad range of indications, including: fractures, leg lengthening, and correction of bone deformity in upper and lower extremities.

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

orthopediatrics aus pty ltd - 58120 - external orthopaedic fixation frame web-based calculator - a stand-alone software application designed provide algorithms to assist a physician/surgeon in performing calculations to help create a schedule for the regular adjustment of an external orthopaedic fixation frame (framework) to help facilitate optimum bone growth for fracture healing. this software performs the necessary mathematical calculations and may provide a visual example of the skeletal deformities. it is intended to be installed on an off-the-shelf computer/smart device as an aid to the clinical judgement of a physician/surgeon in a clinic or hospital environment.

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

orthopediatrics aus pty ltd - 33187 - fixation device, internal, nail, intramedullary, femur - the pediflex? flexible nail system is intended for fixation of diaphyseal fractures of long bones where the medullary canal is narrow or flexibility of the implant is required. this includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small stature patients. in pediatric patients, the flexibility of the nail allows it to be inserted at a point that does not disturb or disrupt the growth plate.

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

orthopediatrics aus pty ltd - 60411 - arthrodesis nail, non-sterile - an implant for alignment, stabilization and fixation of long bones that have been surgically prepared (osteotomy) for correction of deformities, or have sustained fractures due to trauma or disease. this includes the femur, tibia, humerus, ulna and fibula in the pediatric population (child and adolescent), and patients with small intramedullary canals affected by skeletal displasias, osteogenesis imperfecta or other bone diseases.