Summary for ARTG Entry:
Lima Orthopaedics Australia Pty Ltd - SMR Revision Stem Ti6Al4V Uncemented - Coated shoulder
humeral stem 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 Revision Stem Ti6Al4V Uncemented - Coated shoulder humeral stem prosthesis
Single Device Product
39702 Coated shoulder humeral stem prosthesis
Revision Humeral Stem designed to provide fixation within the proximal humerus and a site of attachment
either a humeral body or a reverse humeral body to position a Glenosphere or humeral head onto to
provide articulation in a shoulder joint replacement.
The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.
The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint
replacement in patients suffering from disability due to: 1) non-inflammatory degenerative joint disease
including osteoarthritis and avascular necrosis; 2) inflammatory degenerative joint disease such as
rheumatoid arthritis; 3) treatment of acute fractures of the humeral head that cannot be treated with other
fracture fixation methods; 4) revision of a failed primary implant.
Length (mm) 150 to 180
Diameter (mm) 13 to 16
No Specific Conditions included on Record
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Produced at 10.11.2017 at 09:32:08 AEDT
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