Summary for ARTG Entry:
Lima Orthopaedics Australia Pty Ltd - SMR Cemented Humeral Stem Ti6Al4V - Uncoated shoulder humeral
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 Cemented Humeral Stem Ti6Al4V - Uncoated shoulder humeral stem prosthesis
Single Device Product
34197 Uncoated shoulder humeral stem prosthesis
A cemented stem made of Ti6Al4V that is position in the humerus and can be fitted with a humeral body
that can be attached to a humeral head or a reverse humeral body that can be fitted with a liner to provide
an articulation surface within the replacement shoulder joint.
The SMR Humeral Stems are 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.
Length (mm) 80
Diameter (mm) 12 to 20
No Specific Conditions included on Record
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Produced at 10.11.2017 at 09:34:53 AEDT
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