Summary for ARTG Entry:
Zimmer Pty Ltd - Repicci II Unicondylar Knee Onlay Poly tibial component - Uncoated unicondylar knee
tibia prosthesis, polyethylene
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. Repicci II Unicondylar Knee Onlay Poly tibial component - Uncoated unicondylar knee tibia prosthesis,
Single Device Product
48069 Uncoated unicondylar knee tibia prosthesis, polyethylene
Arcom UHMWPE onlay tibial component designed to be seated onto the prepared tibial surface; the
implant bone interface uses 4 pegs for rotational stability and added fixation. Reconstruction with this
implant rebalances the knee utilizing the remaining undisturbed compartmental structures and appropriate
soft tissue tensions as reference points.
Arcom UHMWPE onlay tibial component of the Repicci Unicondylar Knee Joint Replacement Prosthesis.
Indications for use: Partial replacement of the articulating surfaces of the knee when only one side of the
joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease,
previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. This device is
intended for cemented use only
Size (mm) 6.5-9.5
Size Extra small-extra large
No Specific Conditions included on Record
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