Summary for ARTG Entry:
Lima Orthopaedics Australia Pty Ltd - SMR Adaptor Taper - 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 Adaptor Taper - Humeral head prosthesis
Single Device Product
48088 Humeral head prosthesis
The SMR adaptor is made of Ti6Al4V and is designed to be inserted into the Humeral Head and is
attached to the humeral body. The Humeral head articulates with the natural glenoid fossa or a
replacement glenoid fossa prosthesis to provide movement within the shoulder joint.
The SMR Humeral Head adaptor 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.
Size Standard to Long
Offset 0 to +8
Shape Neutral and Eccentric
No Specific Conditions included on Record
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Produced at 10.11.2017 at 12:09:26 AEDT
This is not an ARTG Certificate document.
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