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510(k) Data Aggregation
K Number
K243950Device Name
ARVIS® Shoulder
Manufacturer
Kico Knee Innovation Company Pty Ltd
Date Cleared
2025-01-13
(21 days)
Product Code
SBF, LLZ, QIH
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
Kico Knee Innovation Company Pty Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ARVIS® Shoulder is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery.
The system aids the surgeon in making intraoperative measurements and locating anatomical structures of the shoulder joint based on the patient's preoperative imaging.
The system is intended to be used with the head mounted ARVIS® Eyepiece display for augmented reality visualization and information, such as visualization of the preoperative plan and display of instrument and implant alignment information. The augmented/ virtual displayed information should not be relied upon solely for absolute positional/alignment information and should always be used in conjunction with the displayed stereotaxic information.
ARVIS® Shoulder is indicated for total shoulder arthroplasty using the Enovis AltiVate, LimaCorporation PRIMA, and LimaCorporation SMR implant systems.
Device Description
ARVIS® Shoulder is a computer-controlled navigation system for shoulder arthroplasty. It aids the surgeon in making intra-operative measurements and locating anatomical structures of the shoulder joint based on the patient's preoperative imaging to assist with selection and positioning of orthopedic implant components. The system consists of software, electronic hardware and surgical instruments.
The ARVIS® Eyepiece is mounted on the surgeon's head and contains tracking cameras that locate the positions of trackers on the patient and instruments. All system measurements, instructions, prompts, and alerts are shown to the surgeon on the Eyepiece display. The Eyepiece communicates with the Belt Pack which is worn by the surgeon around their waist and houses the computer module that runs the ARVIS® Shoulder application software.
The device's workflow involves CT based preoperative planning followed by intraoperative navigation and execution. The preoperative planning software enables 3D virtual implant positioning based on the patient's CT reconstructed digital bone model and bony landmarks. The shoulder navigation software then matches the patient's digital bone model and landmarks to the intraoperative landmarks registered by the surgeon, allowing an image-based navigation to follow. The surgeon uses the plan data as guidance to navigate and help position shoulder instruments and implants.
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K Number
K242009Device Name
360CAS Knee
Manufacturer
Kico Knee Innovation Company Pty Ltd
Date Cleared
2024-08-08
(29 days)
Product Code
OLO
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
Kico Knee Innovation Company Pty Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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.
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