Summary for ARTG Entry:
Lima Orthopaedics Australia Pty Ltd - SMR Humeral Head CoCrMo - Humeral head prosthesis
ARTG entry for
Medical Device Included Class III
Lima Orthopaedics Australia Pty Ltd
Unit 1 40 Ricketts Road,MOUNT WAVERLEY, VIC, 3149
ARTG Start Date
Medical Device Class III
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
Via Nazionale 52
Villanova San Daniele del Friuli, Udine, 33038
1. SMR Humeral Head CoCrMo - Humeral head prosthesis
Single Device Product
48088 Humeral head prosthesis
The Humeral Head is made of CoCrMo and is attached to the humeral body via a humeral head adaptor
and combined they provide articualtion in the shoulder joint with the natural glenoid fossa or a replacement
glenoid fossa prosthesis to provide movement.
The SMR Humeral Head is part of the SMR Shoulder System which is intended for partial or total, primary
or revision shoulder joint replacement suffering from disability due to, non-inflammatory degenerative joint
disease including osteoarthritis and avascular necrosis, inflammatory degenerative joint disease such as
rheumatoid arthritis, treatment of acute fractures of the humeral head that cannot be treated with other
fracture fixation methods and revision of a failed primary implant.
Shape Standard or Flattened
Diameter (mm) 38 to 54
Offset 2 - 4 mm Eccentric
No Specific Conditions included on Record
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Produced at 10.11.2017 at 12:08:39 AEDT
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