Summary for ARTG Entry:
Lima Orthopaedics Australia Pty Ltd - SMR MB Liner UHMWPE - Prosthesis, internal, joint, shoulder,
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 MB Liner UHMWPE - Prosthesis, internal, joint, shoulder, glenoid component
Single Device Product
36259 Prosthesis, internal, joint, shoulder, glenoid component
The metal Back Poly Liner is made of UHMWPE and is inserted into the Metal Back Glenoid to provide a
surface for the humeral head to articulate on.
The Metal Back Poly Liner is part of the SMR Shoulder System which is intended for partial, total, Primary
or Revision shoulder joint replacement when 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 Small R to Large
No Specific Conditions included on Record
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Produced at 10.11.2017 at 12:08:55 AEDT
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