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360CAS Knee

Kico Knee Innovation Company Pty, Ltd.

Country / Region:Australia (AU)Submission type:Special

Product code OLO· 21 CFR 882.4560

Summary PDF

Product code

OLO
21 CFR 882.4560

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K242009
Device name
360CAS Knee
Country / Region
Australia(AU)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2024-07-10
Decision date
2024-08-08
Submission type
Special
Technology type
Image Guided Surgery(AI inferred)
Clinical applications
Knee SurgeryNavigation System
Primary application
Knee Surgery
Classification source
AI classified

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

Intended 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.

Device Description

The 360 Computer Assisted Surgery (360CAS) is a stereotaxic surgical navigation system designed for orthopedic surgical procedures. The 360CAS device consists of four main components: 360CAS Navigation Software, Surgical Instruments, Spatial Tracking Components, and the Navigation Cart. It is intended to be used as a planning and intraoperative guidance system in open or percutaneous orthopedic surgical procedures. This device utilizes optical tracking technology, enabling surgeons to map patient morphology, navigate surgical instruments, and assess joint conditions throughout the surgery. Optical trackers are attached to navigation instruments, and the Spatial Tracking Components locate the 3D position of these instruments in space. The coordinates are relayed to the 360CAS Navigation Software, which provides the user with relevant orientation and position information. The 360CAS Knee is a specific application of the 360CAS Navigation Software tailored for knee replacement surgery.

Summary parsed at:2026-06-19 05:34:23 UTC

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