Summary for ARTG Entry:
Smith & Nephew Pty Ltd - Spectron EF Primary 12/14 Taper CoCr Femoral Component - Uncoated femoral
stem prosthesis, modular
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 Inc Orthopaedic Division
1450 E Brooks Road
Memphis, TN, 38116
United States Of America
1. Spectron EF Primary 12/14 Taper CoCr Femoral Component - Uncoated femoral stem prosthesis, modular
Single Device Product
34203 Uncoated femoral stem prosthesis, modular
A cobalt chrome alloy cemented femoral hip stem which features: a roughened proximal surface which
increases the implant surface area leading to a stronger bond at the implant/cement interface;
a polished circulotrapezoidal neck for increased range of motion of the joint and decreased impingement
and dislocation; 12/14 taper compatibility with 12/14 taper femoral head; and, a rectangular cross section
through the distal portion of the stem for rotational stability.
A sterile cobalt-chrome femoral component of a total hip system intended to be used with bone cement.
Hip components are indicated for individuals undergoing primary and revision surgery where other
treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory
degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis,
traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid
arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of
nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement
that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone
resection; fracture/dislocation of the hip; and correction of deformity.
Size 1H-5H High
Offset Standard and High
Size 1-5 Standard
Length (mm) 115-135
No Specific Conditions included on Record
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