Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ARVIS Surgical Navigation System

K-Number: K243980 · 2025-03-21

ApplicantKico Knee Innovation Company Pty Limited
Decision Date2025-03-21
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ARVIS Surgical Navigation System is a medical device manufactured by Kico Knee Innovation Company Pty Limited. It received FDA 510(k) clearance on 2025-03-21 under approval number K243980. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARVIS Surgical Navigation System?

ARVIS Surgical Navigation System is a medical device that received FDA 510(k) clearance on 2025-03-21. It is manufactured by Kico Knee Innovation Company Pty Limited. The 510(k) number is K243980.

When was ARVIS Surgical Navigation System approved by the FDA?

ARVIS Surgical Navigation System received FDA 510(k) clearance on 2025-03-21, under approval number K243980.

What company makes ARVIS Surgical Navigation System?

ARVIS Surgical Navigation System is manufactured by Kico Knee Innovation Company Pty Limited.

What is the FDA product code for ARVIS Surgical Navigation System?

The FDA product code for ARVIS Surgical Navigation System is SBF.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT05764954 A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42184430 Navigation-guided endoscopic transcerebellar approach for cyst fenestration of a dorsal brainstem lesion: illustrative case. Journal of neurosurgery. Case lessons (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Kico Knee Innovation Company Pty Limited

K163405360KS Implant Positioning System K213380360CAS K223927360CAS

Related Devices (Code: SBF)

K190929xvision Spine system (XVS)Augmedics, Ltd. K202152NextAR TKA PlatformMedacta International S.A. K193559NextAR TKA PlatformMedacta Inernational SA K210859NextAR™ Spine PlatformMedacta International S.A. K211188xvision Spine system (XVS)Augmedics, Ltd. K210153NextAR RSA PlatformMedacta International S.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑