Summary for ARTG Entry:
Stryker Australia Pty Ltd - OMNIFIT EON PLUS 127? CEMENTED HIP STEM - Uncoated hip femur
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. OMNIFIT EON PLUS 127? CEMENTED HIP STEM - Uncoated hip femur prosthesis, one-piece
Single Device Product
34223 Uncoated hip femur prosthesis, one-piece
A sterile implantable modular Femoral Hip Stem designed to replace the proximal femoral neck as part of
a Total Hip Arthroplasty (THA). Designed with a collar to make contact with the proximal femur/ calcar.
Designed for a compatible Femoral Head to be attached and to articulate with an appropriate Acetabular
Component as part of a Total Hip Arthroplasty (THA). Made of forged Cobalt Chrome and intended for use
A component of a total hip joint prosthesis that is used to replace the femoral neck.
For use as a Bipolar Hip Replacement: Femoral head/neck fractures or non-unions. Aseptic necrosis of the
femoral head. Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular
involvement or distortion.
Other Considerations: Pathological conditions or age considerations which indicate a more conservative
acetabular procedure and an avoidance of the use of bone cement in the acetabulum. Salvage of failed
total hip Arthroplasty.
Length (mm) Stem 100mm - 150mm
Length (mm) Neck 25mm - 40mm
Offset Base 33mm - 53mm
Diameter (mm) Distal Tip 8.1mm - 14.8mm
No Specific Conditions included on Record
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