Summary for ARTG Entry:
Smith & Nephew Pty Ltd - EP-FIT PLUS REXPOL Insert Standard - 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 Standard - 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. The ideal insert to
be used with the acetabular shell is determined by using insert trials. Following trialing, the REXPOL insert
is impacted using an inserter/impactor or if a 36mm insert is used, it should be placed manually or with the
insert positioning instrument. The primary seating of the REXPOL insert may be checked using a rasp.
An acetabular component of the EP-FIT PLUS Press-fit cup system. The EP-FIT PLUS REXPOL Insert
Standard 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
Diameter (mm) Femoral Head Diameter 28mm
Size 46 to 68
No Specific Conditions included on Record
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Produced at 09.11.2017 at 09:02:37 AEDT
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