Summary for ARTG Entry:
Lima Orthopaedics Australia Pty Ltd - SMR Adaptor 36mm for Reverse Humeral Body Ti6AI4V - 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 Adaptor 36mm for Reverse Humeral Body Ti6AI4V - Humeral head prosthesis
Single Device Product
48088 Humeral head prosthesis
The SMR Adapter is inserted into the Reverse Humeral Body to accommodate the fitting of the Reverse
CTA Humeral Head. The CTA Humeral head articulates with the Reverse Glenosphere or replacement
Glenoid fossa prosthesis to provide movement within the shoulder joint.
The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder
replacement in a grossly rotator cuff deficient joint with severe arthropathy (disable shoulder). The SMR
Adaptor 36mm for Reverse Humeral Body is inserted into the SMR Reverse Humeral Body which is
attached to the humeral Stem. The intended purpose of the SMR Adaptor 36mm for Reverse Humeral
Body is to hold either the SMR Reverse Humeral Head or SMR Reverse CTA Humeral Head in place.
Nil variant (as 1 device) Nil
No Specific Conditions included on Record
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