Summary for ARTG Entry:
MicroPort Orthopedics Pty Ltd- PROFEMUR® L Classic Hip HA Coated - Press-fit hip femur prosthesis,
ARTG entry for
Medical Device Included Class III
MicroPort Orthopedics Pty Ltd
PO Box 6052,Frenchs Forest, NSW, 1640
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.
MicroPort Orthopedics Inc
5677 Airline Road
Arlington, TN, 38002
United States Of America
1. PROFEMUR® L Classic Hip HA Coated - Press-fit hip femur prosthesis, one-piece
Single Device Product
55834 Press-fit hip femur prosthesis, one-piece
This fixed neck femoral stem has a rectangular cross-section and longitudinal grooves distally. Proximally,
the stem has a trapezoidal cross-section and surface grooves perpendicular to stem longitudinal axis and
parallel with each other on anterior, posterior, and medial sides. It is offered in 11 sizes in either a standard
(neutral neck offset) or extended (8° varus neck offset) configuration to accommodate varying patient
A total hip system component intended to replace the femur. Indications include use in total hip
arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the
1.non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis,
protrusio acetabuli, and painful hip dysplasia;
2.inflammatory degenerative joint disease such as rheumatoid arthritis;
3.correction of functional deformity; and,
4.revision procedures where other treatments or devices have failed.
Offset Standard (Neutral)
Offset Extended (8° Varus)
No Specific Conditions included on Record
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Produced at 24.11.2017 at 02:13:12 AEDT
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