# K223927: 360CAS

- Pathway: 510(k) (Special)
- Applicant: Kico Knee Innovation Company Pty Limited
- Decided: Jan 27, 2023 after 28 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: 6 generations back to K993239 (2000). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213380: 360CAS, Kico Knee Innovation Company Pty Limited (2022) Summary page 5.

## Most influential descendants
- K242009: 360CAS Knee (2024), 0 descendants of its own

## Indications for use
The 360CAS is indicated for patients undergoing orthopaedic surgery and where reference to a rigid anatomical structure can be identified. The 360CAS Knee is indicated for the following surgical procedures: • Any form of Total Knee Arthroplasty (TKA) • For conditions of the knee joint in which the use of computer assisted surgery may be appropriate The 360CAS Hip is indicated for the following surgical procedures: • Any form of Total Hip Arthroplasty (THA) e.g., open or minimally invasive, where a posterior or anterior approach is used • For conditions of the hip joint in which the use of computer assisted surgery may be appropriate

Source page: https://510kreport.com/device/K223927
Methodology: https://510kreport.com/methodology