Summary for ARTG Entry:
Smith & Nephew Pty Ltd - EP-FIT PLUS BIOLOX Delta Ceramic Insert - Ceramic acetabular liner
ARTG entry for
Medical Device Included Class III
Smith & Nephew Pty Ltd
PO Box 393, North Ryde, NSW, 1670
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.
Smith & Nephew Orthopaedics AG
Baar, , 6340
1. EP-FIT PLUS BIOLOX Delta Ceramic Insert - Acetabulum prosthesis - Ceramic acetabular liner
Single Device Product
48055 Ceramic acetabular liner
A sterile ceramic (Al203 ZrO2) acetabular insert to be used in combination with a ceramic ball head.
Following trialling with a trial head the insert may be placed into the acetabular shell by hand or with the
insert positioning instrument. The alignment guide should be used to aid with positioning. Positioning can
be verified by making sure the shell and insert sit flush, and the insert is fixed into place using the
An acetabular component of the EP-FIT PLUS Press-Fit cup system. The EP-FIT PLUS BIOLOX Delta
Ceramic Insert is intended to be used for the following indications:
· All forms of arthritis
· Progressive loss of function of the hip joint as a result of degenerative posttraumatic or
inflammatory/rheumatic destruction of the joint
· Femoral head necrosis
· Fractures in the region of the femoral neck or hip joint
· Status following earlier operations such as osteosynthesis, corrective osteotomies, stiffening or joint
Size 46- 68
Diameter (mm) Inner 32 - 36
Diameter (mm) Outer 39 - 52
No Specific Conditions included on Record
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Produced at 09.11.2017 at 09:03:11 AEDT
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