오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

amplitude australia pty ltd - 48068 - uncoated unicondylar knee tibia prosthesis, metallic - the fixed bearing tibial tray is manufactured from cocr with a polished surface to improve resistance to backside wear. it is a symmetrical baseplate with a continuous peripheral rim around the tibial tray facilitates secure locking mechanism. the device for cemented fixation. the uni score fixed tibial component cemented forms part of the uni score knee system that is intended for use in any disease to the internal or external femoro-tibial joint of the knee caused by degenerative or congenital disorders, inflammatory, or post-traumatic affection.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 32832 - uncoated knee tibia prosthesis, metallic - tibial tray component of the nexgen? complete knee solution mis (minimally invasive solutions) system used in minimally invasive total knee arthrotomy and total knee procedures utilising a larger incision. it is made from tivanium? ti-6al-4v alloy and trabecular metal (tantalum) material (tm) and may be used with or without bone cement (biological fixation). the nexgen? complete knee solution, zimmer? mis solutions procedures, trabecular metal technology, tibial tray, fixed bearing is intended to repair or replace the tibial knee joint for patients with severe knee pain and disability due to: - rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis - collagen disorders, and/or avascular necrosis of the femoral condyle - post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy - moderate valgus, varus, or flexion deformities - the salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 46585 - prosthesis, knee, internal, insert component - the pfc sigma tc3 fixed bearing inserts are made from uhmwpe and reinforced with titanium pins. the pin is part of the spine and protrudes down through the bottom of the insert. it is inserted into the hole of the modular tibial tray. the pfc sigma tc3 fixed bearing insert locks into the tibial tray and articulates with the femoral component. p.f.c sigma tc3 tibial fixed bearing inserts are offered in the same sizes as the femoral components with dimensions that correspond to the tibial tray. the pfc sigma tc3 fixed bearing insert is the articulating component of a total knee arthroplasty and for revision of failed knee prostheses. it is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation patients where there is evidence of sufficient sound bone to seat and support the components. candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implant.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 46585 - prosthesis, knee, internal, insert component - the pfc sigma stabilised xlk fixed bearing insert articulates with the femoral implant and snap locks into the tibial tray of a knee joint prosthesis. it is a one-piece contoured polyethylene (pe) insert. the pfc sigma stabilised xlk fixed bearing insert is the articulating component of a total knee arthroplasty and is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implant.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

nipro australia pty ltd - 38501 - insulin syringe, fixed-needle - syringe with needle is to inject medication to an accurately measured dose.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

medacta australia pty ltd - 34198 - coated knee tibia prosthesis - the gmk primary fixed cementless tibial tray is an asymmetric design which maximises bone coverage, assures optimal load distribution and avoids overhanging risk. the mirror polished surface of the tibial baseplate minimises backside wear, and the inlay clipping mechanism assures time-effective and safe implantation. the tibial tray is made from cocrmo with uhmwpe plug, ti coating, and ha coating. gmk standard cementless tibial component forms part of the gmk primary knee system that is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint, if there is evidence of sufficient sound bone to seat and support the components, and is available for primary and revision surgery. candidates for the total knee replacement are patients with a severely painful and/or severely disabled joint as a result of osteoarthritis, post-traumatic arthritis, rheumatoid polyarthritis, or primary implantation failure.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 46585 - prosthesis, knee, internal, insert component - the pfc sigma stabilised gvf fixed bearing tibial insert with i2 lock articulates with the femoral component and locks into the tibial tray by an i2 locking mechanism. it is a one-piece contoured polyethylene insert and packed in gamma vacuum foil (gvf) for increased wear resistance. the pfc sigma stabilised gvf fixed bearing tibial insert with i2 lock is the articulating component of a total knee arthroplasty and is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. total knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. this includes severely crippled patients with multiple joint involvement for whom a gain in knee mobility may lead to an expectation of significant improvement in the quality of their lives. candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

medacta australia pty ltd - 48069 - uncoated unicondylar knee tibia prosthesis, polyethylene - the gmk uni fixed insert is designed to be used as part of the gmk uni knee system that provides round-on-flat articulation which avoids unwanted stress on the tibial compartment and the mirror polished fixed tibial baseplate minimises backside wear of the uhmwpe insert component. the gmk uni fixed tibial inserts form part of the gmk uni knee system that is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint, if there is evidence of sufficient sound bone to seat and support the components. in unicompartmental knee arthroplasty, only one compartment of the joint is affected (the medial or lateral compartment).

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

medacta australia pty ltd - 48068 - uncoated unicondylar knee tibia prosthesis, metallic - the gmk uni fixed cemented tibia forms part of the gmk uni knee system. the tibia has a stabilisation fin and an oblique fixation peg to ensure optimal primary fixation and ease implant positioning. the gmk uni fixed cemented tibial trays form part of the gmk uni knee system that is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint, if there is evidence of sufficient sound bone to seat and support the components. in unicompartmental knee arthroplasty, only one compartment of the joint is affected (the medial or lateral compartment).

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

amplitude australia pty ltd - 46585 - prosthesis, knee, internal, insert component - the fixed bearing insert is made from machined ultra-high molecular weight polyethylene (uhmwpe). the insert has curved anterior lip to ensure joint stability throughout range of motion.the polyethylene insert is thicker in posteroinferior part of post where it makes contact with posterior stabilisation cam. the fixed bearing insert is a component of the anatomic? total knee system that is indicated for primary or secondary osteoarthritis, including revision of an osteotomy;osteonecrosis;rheumatoid arthritis;post-traumatic osteoarthritis;primary tkp is indicated for revising unicompartmental or femoropatellar prostheses.