Manufacturer
Kico Knee Innovation Company Pty, Ltd.360CAS Knee
Kico Knee Innovation Company Pty, Ltd.
Country / Region:Australia (AU)Submission type:Special
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
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
Predicate devices
1K242009 references 1 predicate/reference device
Cited as predicate
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