# K060412: Active Unicompartmental Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Australian Surgical Design & Manufacture
- Decided: May 17, 2006 after 90 days
- Product code: HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K971938 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971938: Repicci II Unicondylar Knee, Biomet, Inc. (1997) Summary page 1.

## Most influential descendants
- K072704: Unicompartmental Knee (2008), 0 descendants of its own

## Indications for use
The Active Unicompartmental Knee System is a modular unicompartmental system that is intended to resurface one diseased or damaged condyle of a knee where the other condyle remains intact. It is intended to be used only with bone cement in patients suffering from the following conditions: Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis. Inflammatory degenerative joint disease excluding rheumatoid arthritis Correction of functional deformity such as varus or valgus deformities.

Source page: https://510kreport.com/device/K060412
Methodology: https://510kreport.com/methodology