Summary for ARTG Entry:
Smith & Nephew Pty Ltd - EP-FIT PLUS REXPOL Insert Hooded - Non-constrained polyethylene
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 REXPOL Insert Hooded - Acetabulum prosthesis - Non-constrained polyethylene acetabular
Single Device Product
43168 Non-constrained polyethylene acetabular liner
A sterile non-cemented REXPOL (highly cross-linked polyethylene) acetabular insert having a raised
shoulder of 15 degrees intended as luxation protection. The insert should be positioned in the direction in
which there is the greatest risk of luxation and the shoulder position of the insert may be adjusted in 30
degree increments. The REXPOL Hooded insert is impacted into the acetabular shell using an
An acetabular component of the EP-FIT PLUS Press-Fit cup system. The EP-FIT PLUS REXPOL Insert
Hooded 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 diameter 28 - 32
No Specific Conditions included on Record
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Produced at 09.11.2017 at 09:02:54 AEDT
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