# K163405: 360KS Implant Positioning System

- Pathway: 510(k) (Traditional)
- Applicant: Kico Knee Innovation Company Pty Limited
- Decided: Mar 21, 2017 after 106 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K896095 (1990). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133022: Zedview, Lexi Co., Ltd. (2014) Summary page 6.

## Indications for use
360KS Implant Positioning System (IPS) is intended for use as patient-specific surgical planning software to aid orthopaedic surgeons in selection, sizing and placement of knee implant components (femur, tibia and patella implants) provided that the required anatomical landmarks of the knee can be identified on pre-operative CT or MRI scans in patients requiring total knee arthroplasty. 360KS IPS is indicated for use with OMNI Life Science Apex Knee System (#K060192, #K073602, #K080842) and Corin Unity Total Knee System (#K113060).

Source page: https://510kreport.com/device/K163405
Methodology: https://510kreport.com/methodology