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

allegra orthopaedics limited - 35685 - fixation device, internal, wire - kirschner wires (k-wires) or steinmann pins (s-pins) have numerous orthopaedics applications and are commonly utilised as a primary or secondary method of fracture fixation. k-wires and s-pins are often utilised to facilitate the union of osteotomies occurring in the phalanges, metacarpals, metatarsals, distal humerus or distal radius. k-wires can be applied in various configurations to allow for rigid fixation, and can also be used with tension wire to further increase stability. similarly, k-wires are utilised in the practice of arthrodesis where the joint space filled with bone graft. as a secondary fixation method, kirschner wires can be used in conjunction with plates or screws to further enhance fixation. k-wire and steinmann pins have successfully been used in the treatment of clavicle, zygomatic, nasal, mandible and a variety of paediatric fractures.

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

allegra orthopaedics limited - 33745 - coated knee femur prosthesis - the femoral component is an anatomic, asymmetrically designed prosthesis manufactured from cast cobalt-chromium-molybdenum (cocrmo). the design incorporates a trochlear groove which conforms to the geometry of the patellar prosthesis and allows for sliding articulation. the femoral implant is available in several sizes to suit different anatomies.the interior of the cementless femoral implant has a hydroxyapatite coating with a beaded distal surface to encourage bony ingrowth on the prosthesis. the cementless femoral implant is a component of the active knee system. the patient should be skeletally mature to receive a knee replacement. patients should have adequate bone stock and size to support prosthesis. it is intended for non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; inflammatory degenerative joint disease including rheumatoid arthritis; functional deformity such as varus, valgus or flexion deformities; revision procedures where other treatments or devices have failed; fractures that are unmanageable using other techniques.

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

allegra orthopaedics limited - 16101 - fixation device, internal, screw - bone screws are used to asist in the fixation of damaged or fractured bone, to attach devices used to assist in the repair of fractured bones, and to attach implantable components to bone.

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

allegra orthopaedics limited - 44054 - surgical procedure kit, orthopaedic, reusable - a collection of various surgical instruments used to perform an orthopaedic surgical procedure. this device is presented as a kit with trays of instruments. the kit is reusable after the appropriate cleaning and sterilizing is performed by the user.

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

allegra orthopaedics limited - 34199 - polyethylene patella prosthesis - the patella component manufactured from ultra-high molecular weight polyethylene (uhmwpe) and has a dome shape with the reverse curvature of the femoral condyles. the patella is designed for fixation with pmma - cement. the patella component is available in several sizes to suit different anatomies. the patella implant is a component of the active knee system. the patient should be skeletally mature to receive a knee replacement. patients should have adequate bone stock and size to support prosthesis. it is intended for non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; inflammatory degenerative joint disease including rheumatoid arthritis; functional deformity such as varus, valgus or flexion deformities; revision procedures where other treatments or devices have failed; fractures that are unmanageable using other techniques.

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

allegra orthopaedics limited - 46585 - prosthesis, knee, internal, insert component - a polyethylene liner component designed to provide the articulating bearing surface between the femoral and tibial components of a total knee replacement. the ultracongruent plus is designed for use in patients with an absent or severely deficient posterior cruciate ligament. the ultracongruent plus mensical insert implant is a component of the active knee system. the patient should be skeletally mature to receive a knee replacement. patients should have adequate bone stock and size to support prosthesis. it is intended for non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; inflammatory degenerative joint disease including rheumatoid arthritis; functional deformity such as varus, valgus or flexion deformities; revision procedures where other treatments or devices have failed; fractures that are unmanageable using other techniques.

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

allegra orthopaedics limited - 46585 - prosthesis, knee, internal, insert component - a polyethylene liner component designed to provide the articulating bearing surface between the femoral and tibial components of a total knee replacement. the ultracongruent is designed with an anterior lip for additional posterior stability. the meniscal ultracongruent insert implant is a component of the active knee system. the patient should be skeletally mature to receive a knee replacement. patients should have adequate bone stock and size to support prosthesis. it is intended for non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; inflammatory degenerative joint disease including rheumatoid arthritis; functional deformity such as varus, valgus or flexion deformities; revision procedures where other treatments or devices have failed; fractures that are unmanageable using other techniques.

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

allegra orthopaedics limited - 34198 - coated knee tibia prosthesis - the stemmed tibial implant is symmetrical. the stemmed implants are manufactured from cast cobalt-chrome-molybdenum (cocrmo). the interior surface of the cementless tibial implants, has a beaded surface and a hydroxyapatite coating to encourage bony ingrowth on the prosthesis. the stemmed tibial implant is a component of the active knee system. the patient should be skeletally mature to receive a knee replacement. patients should have adequate bone stock and size to support prosthesis. it is intended for non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; inflammatory degenerative joint disease including rheumatoid arthritis; functional deformity such as varus, valgus or flexion deformities; revision procedures where other treatments or devices have failed; fractures that are unmanageable using other techniques.

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

allegra orthopaedics limited - 32832 - uncoated knee tibia prosthesis, metallic - the stemmed tibial implant is symmetrical. the stemmed implants are manufactured from cast cobalt-chrome-molybdenum (cocrmo). the cemented tibial implant has a grit blast finish on the interior surfaces. the stemmed tibial implant is a component of the active knee system. the patient should be skeletally mature to receive a knee replacement. patients should have adequate bone stock and size to support prosthesis. it is intended for non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; inflammatory degenerative joint disease including rheumatoid arthritis; functional deformity such as varus, valgus or flexion deformities; revision procedures where other treatments or devices have failed; fractures that are unmanageable using other techniques.

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

allegra orthopaedics limited - 32831 - uncoated knee femur prosthesis - the femoral component is an anatomic, asymmetrically designed prosthesis manufactured from cast cobalt-chromium-molybdenum (cocrmo). the design incorporates a trochlear groove, which conforms to the geometry of the patellar prosthesis and allows for sliding articulation. the cemented femoral implant has a grit blast finish on the interior surfaces for enhanced polymethylmethacrylate (pmma) fixation. the cemented femoral implant is a part of the active knee system for skeletally mature patients which have adequate bone stock. intended for non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; inflammatory degenerative joint disease including rheumatoid arthritis; functional deformity such as varus, valgus or flexion deformities; revision procedures where other treatments or devices have failed; fractures that are unmanageable using other techniques.