Summary for ARTG Entry:
Stryker Australia Pty Ltd - Modular Dual Mobility (MDM) LINER - Metallic acetabular liner
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. Modular Dual Mobility (MDM) LINER - Metallic acetabular liner
Single Device Product
48056 Metallic acetabular liner
This Acetabular Liner is the middle portion of an artificial three-piece acetabular component that is sterile
and made of Cobalt Chrome. This device is inserted into an Acetabular Shell and articulates with a
corresponding Acetabular Insert. The Acetabular Insert further articulates with an artificial Femoral Head
as part of a Total Hip Arthroplasty (THA). Facilitates a Trident locking mechanism, this will allow for
compatibility with an Acetabular Shell containing the same locking mechanism.
A component of a total hip joint prosthesis that is used to replace or repair the acetabulum.
The indications for use for total hip arthroplasty include:
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and,
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head
involvement that are unmanageable using other techniques.
6. Dislocation risks
RESTORATION ADM HA Cups and MDM Liners are intended for cementless use only.
Diameter (mm) Outer 36mm - 58mm
No Specific Conditions included on Record
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