Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
B Braun Australia Pty Ltd - Aesculap Patella 3-Pegs - Cruciate-retaining total knee prosthesis
ARTG entry for
Medical Device Included Class III
B Braun Australia Pty Ltd
PO Box 6221,BAULKHAM HILLS DC, NSW, 2153
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.
AM Aesculap Platz
Tuttlingen, , D-78532
1. Aesculap Patella 3-Pegs - Cruciate-retaining total knee prosthesis
Single Device Product
33664 Cruciate-retaining total knee prosthesis
The Universal Patella is used to resurface the Patella in either primary or revision total knee arthroplasty
and is compatible with the implant systems Vega, e.motion, Columbus and EnduRo. The rear of the patella
implant has 3 pegs for fixation in the bone. Cement pockets on the under surface of the patella guarantee
the minimum thickness of the cement mantle. The Patella implants are made out of UHMWPE and include
X-Ray markers made out of Stainless steel.
The implant is used as a component part of a human knee endoprosthesis in combination with Aesculap
knee endoprosthetic components. Indicated for use in severe knee joint conditions that cannot be treated
through other therapies:
· Degenerative osteoarthritis
· Rheumatoid arthritis
· Posttraumatic arthritis
· Symptomatic knee instability
· Knee stiffness
· Deformation of the knee joint
The surgeon can select the optimum solution for the patient from the various implant types of the knee
systems, according to the severity of the condition. The surgeon is responsible for correctly establishing
Size (mm) 26 x 7
Size (mm) 29 x 8
Size (mm) 32 x 9
Size (mm) 35 x 10
Size (mm) 38 x 11
No Specific Conditions included on Record
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Produced at 22.11.2017 at 09:36:10 AEDT
This is not an ARTG Certificate document.
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