# K213380: 360CAS

- Pathway: 510(k) (Traditional)
- Applicant: Kico Knee Innovation Company Pty Limited
- Decided: Jan 11, 2022 after 90 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: 5 generations back to K993239 (2000). 12 ancestors in all.
2 later devices descend 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)
- K162341: Stryker OrthoMap Precision Knee system, Stryker Leibinger GmbH & Co KG (2016) Summary page 4.
- K162937: Stryker OrthoMap Versatile Hip System, Stryker Corporation (2017) Summary page 4.

## Most influential descendants
- K223927: 360CAS (2023), 1 descendant of its own
- K242009: 360CAS Knee (2024), 0 descendants of its own

## Indications for use
The 360CAS is intended to be used as a planning and intraoperative guidance system to enable open or percutaneous image guided surgical procedures. The 360CAS 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 The 360CAS Hip is indicated for the following surgical procedures: - 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/K213380
Methodology: https://510kreport.com/methodology