Kico Knee Innovation Company: Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Cata

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand: Kico Knee Innovation Company
Product: Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.1.2 Product Description: Intended Use: 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. Description: ARVIS Shoulder is a computer-controlled surgical 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 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 application 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.
Reason / hazard: Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.
Classification: Class II
Status: Ongoing
Distribution / sold at: US Nationwide distribution in the states of IN, MN, MO, OH, FL, IL, RI, KY, CA, WI, MI, PA, WA, CO, AL.
Recall initiated: 2025-09-19
Code info: Software Version V2025.1.2
Product quantity: 21 systems
Voluntary mandated: Voluntary: Firm initiated
City: Pymble
Country: Australia
Event id: 97618

Kico Knee Innovation Company: Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.