Summary for ARTG Entry:
Zimmer Biomet Pty Ltd - Biomet Series A Patella three peg - Polyethylene patella prosthesis
ARTG entry for
Medical Device Included Class III
Zimmer Biomet Pty Ltd
Locked Bag 1310,FRENCHS FOREST, NSW, 2086
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.
56 East Bell Drive
Warsaw, IN, 46581
United States Of America
1. Biomet Series A Patella three peg - Polyethylene patella prosthesis
Single Device Product
34199 Polyethylene patella prosthesis
Arcom UHMWPE domed patella implant with three pegs. Available in standard or thin profile, for use with
femoral implant; intended for cemented use.
Polyethylene patella component for use during knee arthroplasty to repair the patella bearing surface.
Device is intended for cemented use and is made of Arcom UHMWPE.
The indications for use: Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis
and/or traumatic arthritis, where one or more compartments are involved; Correction of varus, valgus or
posttraumatic deformity; Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of
previous joint replacement procedure.
Thickness Thin 6.2-8.5MM
Thickness Standard 8-10MM
Diameter (mm) 25-40
No Specific Conditions included on Record
© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.
Page 1 of
Produced at 10.11.2017 at 06:20:01 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information