Summary for ARTG Entry:
Stryker Australia Pty Ltd - RESTORATION MODULAR FLUTED DISTAL STEM - Body femoral extension
ARTG entry for
Medical Device Included Class III
Stryker Australia Pty Ltd
PO Box 970,ARTARMON, NSW, 1570
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.
Howmedica Osteonics Corporation
325 Corporate Drive
Mahwah, New Jersey, 07430
United States Of America
1. RESTORATION MODULAR FLUTED DISTAL STEM - Body femoral extension
Single Device Product
33714 Body femoral extension
A sterile distal extension stem designed to connect intraoperatively with a Restoration Modular Femoral
Body. When connected together they are designed to replace the proximal femoral neck. Further it is
intended to be assembled Intraoperatively with a Femoral Head. Made of Titanium Alloy and intended to
be pressfit into the bone without the use of cement.
The RESTORATION Modular Hip System is intended for primary and revision total hip arthroplasty as well
as in the presence of severe bone loss. These femoral stems are designed to be press fit into the proximal
· Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
· Rheumatoid arthritis (except the OSTEOLOCK HA Acetabular Cup);
· Correction of functional deformity;
· Revision procedures where other treatments or devices have failed; and,
· Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head
involvement that are unmanageable using other techniques.
Diameter (mm) 11 - 26
Length (mm) 127 - 317
No Specific Conditions included on Record
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