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Defining joint replacement medical devices and ancillary medical devices

Guidance document

20 April 2015

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Definitions

Definitions have been included in the dictionary of the Therapeutic Goods (Medical Devices) Regulations 2002 for:

Joint replacement medical device means an implantable medical device:

  1. 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
  2. that (either alone or together with one or more other implantable medical devices);
    1. replaces or substitutes for the articulating surface of a shoulder joint, hip joint or knee joint (in whole or in part); or
    2. provides primary fixation to the bone for the replacement articulating surface; or
    3. 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;
  3. but does not include ancillary devices.

Ancillary medical device means an implantable medical device that:

  1. consists of screws, plates or wedges; or
  2. is intended by the manufacturer to be used to:
    1. 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
    2. provide bone substitution in relation to, or additional fixation for, any such device; or
    3. otherwise assist any such device;
  3. 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:

  1. the articulations between each of the 2 condyles of the femur and corresponding surface of the tibia; and
  2. 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.

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