Joint replacement medical device means an implantable medical device:
that is intended by the manufacturer to operate (either alone or together with one or more other implantable medical devices) as a replacement (in whole or in part) for the shoulder joint, hip joint or knee joint; and
that (either alone or together with one or more other implantable medical devices);
replaces or substitutes for the articulating surface of a shoulder joint, hip joint or knee joint (in whole or in part); or
provides primary fixation to the bone for the replacement articulating surface; or
connects directly or indirectly with an implantable medical device that has a function mentioned in subparagraph (i) or (ii) and operates as an intrinsic element of the joint replacement;
but does not include ancillary devices.
Ancillary medical device means an implantable medical device that:
consists of screws, plates or wedges; or
is intended by the manufacturer to be used to:
provide stability for an implantable medical device that is intended to (either alone or together with one or more other implantable medical devices) replace the shoulder joint, hip joint or knee joint; or
provide bone substitution in relation to, or additional fixation for, any such device; or
otherwise assist any such device;
where the individual requirements of a patient make it appropriate to do so.
Hip joint means the ball and socket formed by the reception of the head of the femur into the cup-shaped cavity of the acetabulum.
Knee joint means the joint consisting of:
the articulations between each of the 2 condyles of the femur and corresponding surface of the tibia; and
the articulation between the patella and the trochlear groove of the femur.
Shoulder joint means the ball-and-socket formed by the reception of the head of the humerus onto the glenoid cavity of the scapula.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.