Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN-29200 Software Version: ARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200) ARVIS Shoulder Software v2.0.3 (IN-23630) Product Description: The ARVIS system is a computer-controlled navigation system intended to provide intra-operative measurements to the surgeon to aid in selection and positioning of orthopedic implant components. The ARVIS Surgical Navigation System 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 such as changes in leg length in Hip Arthroplasty. The system is compatible with straight acetabular impactors and with specific offset impactors, identified in the instructions for use, for which an adapter has been validated. Example orthopedic surgical procedures include but are not limited to: " Total Knee Arthroplasty " Unicompartmental Knee Arthroplasty: Tibial Transverse Resection " Hip Arthroplasty The ARVIS" head mounted display is for displaying augmented reality visualization and information to the user intraoperatively. 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. Component: NA

Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing

On 07/13/2026, an "Urgent: Medical Device Recall (Correction)" Letter was email to customers informing them that, KICO has received complaints indicating that the image displayed within the ARVIS eyepiece may appear tilted relative to the eyepiece housing. The display tilt is a persistent condition rather than intermittent or periodic. When the issue occurs, the calibration parameters within an internal sensor change, resulting in a constant offset in the displayed orientation. Once this occurs, the display tilt is consistently present each time the device is powered on and used until the sensor is recalibrated and the firmware correction is implemented. Customers are instructed to: 1. Do not use the ARVIS Gen 2 Navigation System for any hip procedures. 2. The ARVIS Gen 2 Navigation System may continue to be used for Knee and Shoulder procedures only, but it is recommended that all units in inventory are turned on in advance of clinical use and that any units evidencing a tilted display be returned for replacement. 3. This notice needs to be passed on to all those who need to be aware within your organization or functions where the potentially affected devices have been transferred. 4. This notice must be physically posted on or near all ARVIS Gen 2 Navigation Systems. 5. Retain a copy of this letter, place a copy where devices are stored, and keep a copy of the acknowledgement form for your files. 6. Complete the attached Acknowledgement Form immediately and return it email to [email protected] 7. The ARVIS Gen 2 Navigation System should always be visually inspected prior to use as stated in the Instructions for Use. 8. Inform KICO of any Adverse Events*/Serious Incidents** or quality problems concerning the use of the subject devices via the standard complaint process. For question - contact either Sr Product Manager at [email protected] (512) 451-3815 or Sr Director, Regulatory Affairs at [email protected] (952) 913-6383