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

zimmer biomet pty ltd - 60512 - shoulder humeral body prosthesis - the ball taper contains a slit ball head and an oval cone. the standard or fracture cone (with anchoring peg) is introduced into the ball-taper component together with a screw, which ensures the slit ball head to fix the head of the prosthesis firmly onto the ball-taper component. the fixed head of the prosthesis is introduced into the as humeral stem, where it is firmly connected and secured against rotation by means of the oval conical coupling. made from titanium alloy (protasul-100, tial). the ball-taper for humeral stems is part of the anatomical shoulder system and is indicated for patients with advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis; fractures or avascular necrosis; conditions consequent to earlier operations; omarthrosis; rheumatoid arthritis; revision of shoulder prosthesis; traumatology: the only cone to be used in traumatological indications is the fracture cone.

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

zimmer biomet pty ltd - 48088 - humeral head prosthesis - the humeral fracture head component is part of the anatomical shoulder fracture system. designed to articulate with the glenoid component, it consists of a humeral head and locking screw, both manufactured from cocrmo wrought alloy (protasul-21wf, cocrmo), as well as a metaphyseal baseplate made from titanium alloy (protasul-100, tial). the baseplate also offer several suture holes to allow initial stable fixation of the humeral tuberosities with sutures. intended for cemented and uncemented use the as fracture head intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi and fracture shoulder arthroplasty in treatment of 3- and 4-part fractures of the proximal humerus with subluxation of the head fragment; 3- and 4-part fractures of the proximal humerus with loosening of the spongiosa in the head fragment; 3- and 4-part fractures of the proximal humerus with additional cross split of the head fragment; fracture instability after o

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

zimmer biomet pty ltd - 60514 - metallic reverse shoulder prosthesis cup - the humeral cup is a component of the anatomical shoulder inverse/reverse shoulder system. the device can be placed onto the humeral stem with the standard oval taper connection. manufactured from titanium alloy (protasul-100, tial). as inverse/reverse humeral cups are indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. the patient?s joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

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

zimmer biomet pty ltd - 48092 - reverse shoulder prosthesis cup - the pe inlay is a component of the anatomical shoulder inverse/reverse system. the pe-inlay features an anti-rotational design and is locked into the humeral cup with a pe snap-fit solution. manufactured from uhmwpe (sulene-pe). the as inverse/reverse humeral pe-inlay is indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. the patient?s joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

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

3dmorphic pty ltd - 15811 - training model, anatomical, - anatomical models to assist surgeons with pre operative planning. improve and simplify the performance of surgical interventions by acting as an aid or reference to elaborate a pre-operative surgical plan, to transfer the plan to surgery and to determine the correct sizing of the fixture(s) eventually required as part of the surgical procedure.

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

emergo asia pacific pty ltd t/a emergo australia - 43829 - pressure measurement/mapping system, anatomical - the xsensor? pressure mapping systems are designed and intended to display the interface pressure distribution between two objects that come into contact. for medical purposes this could be a patient and a support surface such as a bed, seat or cushion. pressure variation is depicted via an image of relative pressures over the sensing area. a clinician may then, if necessary, take the most appropriate measures to enhance, or even-out, the pressure distribution for the particular patient. the device only measures pressure at the support surface. the device is not intended to measure: ? quantitatively a physiological or anatomical parameter ? a quantity or a qualifiable characteristic of energy or of substances delivered to or removed from the human body.

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

bilby shoes - 43829 - pressure measurement/mapping system, anatomical - a mains electricity (ac-powered), electronic evaluative system, intended for medical purposes, used to evaluate the actual pressure between an anatomical surface and supporting media. typically using an array of pressure sensors the system will provide a map of applied pressure between the supporting surface and the anatomical shape of the patient. types of sensors vary in size and shape to fit different portions of the human body.

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

healthcare innovations australia pty ltd - 43829 - pressure measurement/mapping system, anatomical - the fsa/boditrak pressure mapping systems are used to display the interface pressure of a person or object and related surfaces. when used for medical purposes this could be a patient on a support service such as a bed, wheelchair back support and cushion or other surfaces. the information shown as an image of relative pressure over the sensing area may assist the prescriber/carer in the process of re-distributing or evening out any peak pressure points that may show up. the device only measures pressure at the support surface, it is not intended to measure: - quantitatively a physiological or anatomical parameter - a quantity or a qualifiable characteristic of energy or of substances delivered to or removed from the human body.

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

anatomicsrx pty ltd - 15811 - training model, anatomical, - a non-sterile patient specific model of an organ (e.g., heart, kidney, lung) or bone(s) intended to be used to assist peri-operative anatomical visualisation and surgical treatment planning. it is created using 3-d printing processes based on patient medical images. it is typically made of a synthetic polymer, marked with a unique patient identifier, and may be sterilised prior to use in sterile fields. the device is intended for multiple uses on the one patient.

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

personalised surgery pty ltd - 15811 - training model, anatomical, - a non-sterile patient specific model of an organ (e.g., heart, kidney, lung) or bone(s) intended to be used to assist peri-operative anatomical visualisation and surgical treatment planning. it is created using 3-d printing processes based on patient medical images. it is typically made of a synthetic polymer, marked with a unique patient identifier, and may be sterilised prior to use in sterile fields. the device is intended for multiple uses on the one patient.