# K242009: 360CAS Knee

- Pathway: 510(k) (Special)
- Applicant: Kico Knee Innovation Company Pty, Ltd.
- Decided: Aug 8, 2024 after 29 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K993239 (2000). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223927: 360CAS, Kico Knee Innovation Company Pty Limited (2023) Summary page 4.

## Indications for use
The 360CAS Knee is intended to be used as a planning and intraoperative guidance system in open or percutaneous image guided surgical procedures. The 360CAS Knee is indicated for patients undergoing orthopaedic surgery and where reference to a rigid anatomical structure, such as the pelvis, femur, or tibia, can be identified. The 360CAS Knee is indicated for the following surgical procedures: - Total Knee Arthroplasty (TKA) - For conditions of the knee joint in which the use of computer assisted surgery may be appropriate

Source page: https://510kreport.com/device/K242009
Methodology: https://510kreport.com/methodology