Summary for ARTG Entry:
Stryker Australia Pty Ltd - Secur-Fit Advanced Hip Stem - Coated hip femur prosthesis, modular
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. Secur-Fit Advanced Hip Stem - Coated hip femur prosthesis, modular
Single Device Product
33581 Coated hip femur prosthesis, modular
A sterile implantable Femoral Hip Stem designed to replace the proximal femoral neck as part of a Hip
Arthroplasty. The proximal region of the stem is coated with PureFix HA over a commercially pure titanium
plasma spray substrate. Intraoperatively assembled with a Stryker V40 femoral head and a compatable
acetabular component. Intended for cementless use only.
A component of a total hip joint prosthesis used to replace the femoral the femoral neck. Indications:
noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid
arthritis; correction of functional deformity; revision procedures where other treatments or devices have
failed; and, nonunions, femoral neck and trochanteric fractures of the proximal femur with head
involvement that are unmanageable using other techniques.
When used with compatible Howmedica Osteonics Constrained Liners, this device is intended for use in
primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss,
soft tissue laxity, neuromuscular disease, or intra-operative instability.
Angle (In degrees) Neck Angle 132
Length (mm) Stem 110 -160
Length (mm) Neck Length 26mm - 40 mm
Offset Femoral Offset 31.5mm - 53.7mm
Diameter (mm) Distal Tip 5.1mm - 10.7mm
Angle (In degrees) Neck Angle 127
No Specific Conditions included on Record
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