Neurology · 510(k) · 2025
ARVIS Shoulder
Kico Knee Innovation Company Pty Ltd. Cleared by FDA on 13 January 2025 under submission K243950, product code SBF (orthopedic augmented reality). What FDA's record says, in FDA's words.
Device record · K243950
- Device. ARVIS ShoulderDEVICE
- Company. Kico Knee Innovation Company Pty Ltd (AU)COMPANY
- Decision. 13 January 2025, 510(k), substantially equivalent (special review); received 23 December 2024DECISION
- Panel. NeurologyPANEL
- Product code. SBF, Orthopedic Augmented RealityCODE
- Regulation. 21 CFR 882.4560, Class IIREG
- Source. FDA database entry · decision document (7 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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.
The product code's definition, from FDA's classification record. An orthopedic augmented reality device provides visual guidance during orthopedic procedures, where the use of stereotaxic navigation is utilized. Visual guidance is displayed as augmented reality stereoscopic images to intraoperatively augment the users field of view.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsmeasurement or quantification
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 4 reports filed against devices carrying product code SBF. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
8 July 2026 · Injury · XVISION SPINE SYSTEM (XVS) · AUGMEDICS LTD. · report 3016571711-2026-00003
AN MIS PROCEDURE WAS PERFORMED ON L4-L5 TO NAVIGATE FOUR SCREWS. FINAL FLUOROSCOPY CONFIRMATION REVEALED THAT THE SCREWS WERE POSITIONED HIGHER THAN THE PLANNED TRAJECTORY, AND THEY WERE SUBSEQUENTLY REMOVED AND SUCCESSFULLY REVISED UNDER FLUOROSCOPY. NO PATIENT HARM WAS REPORTED. THE INVESTIGATION ATTRIBUTED THE EVENT TO INTRAOPERATIVE INSTABILITY AND CONSECUTIVE SHIFTS OF THE PERC PIN REFERENCE PLATFORM, LIKELY CAUSED BY INADEQUATE SEATING WITHIN THE PSIS BONE COMBINED WITH HIGHLY UNSTABLE […]
6 May 2026 · Injury · XVISION SPINE SYSTEM (XVS) · AUGMEDICS INC. · report 3016566146-2026-00001
AN OPEN SPINAL PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, NAVIGATION INACCURACIES WERE IDENTIFIED AT L2 AND S1, AND THE SCREWS WERE SUBSEQUENTLY REVISED UNDER FLUOROSCOPY. NO PATIENT HARM WAS REPORTED. THE INVESTIGATION ATTRIBUTED THE EVENT TO A PLATFORM SHIFT OF THE REFERENCE ASSEMBLY, LIKELY CAUSED BY INTRAOPERATIVE RETRACTOR MANIPULATION AND SUBOPTIMAL PIN SEATING. WHILE USER ERROR REMAINS THE MOST REASONABLE ASSUMPTION, A DEFINITIVE ROOT CAUSE COULD NOT BE CONCLUSIVELY CONFIRMED. AS […]
6 May 2026 · Injury · XVISION SPINE SYSTEM (XVS) · AUGMEDICS LTD. · report 3016571711-2026-00002
AN OPEN SPINAL PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, NAVIGATION INACCURACIES WERE IDENTIFIED AT L2 AND S1, AND THE SCREWS WERE SUBSEQUENTLY REVISED UNDER FLUOROSCOPY. NO PATIENT HARM WAS REPORTED. THE INVESTIGATION ATTRIBUTED THE EVENT TO A PLATFORM SHIFT OF THE REFERENCE ASSEMBLY, LIKELY CAUSED BY INTRAOPERATIVE RETRACTOR MANIPULATION AND SUBOPTIMAL PIN SEATING. WHILE USER ERROR REMAINS THE MOST REASONABLE ASSUMPTION, A DEFINITIVE ROOT CAUSE COULD NOT BE CONCLUSIVELY CONFIRMED. AS […]
8 September 2025 · Injury · ONPOINT SURGICAL SYSTEM · ONPOINT SURGICAL, INC. · report 3016534677-2025-00001
AN MIS SURGERY ON THE LUMBAR SPINE WITH FUSION OF AND SCREW PLACEMENT IN VERTEBRAE L4 AND L5 (4 PEDICLE SCREWS TOTAL) WAS PERFORMED WITH THE AID OF THE ONPOINT SPINE SYSTEM. PATIENT WAS POSITIONED PRONE ON THE OPERATING ROOM TABLE. SURGEON ATTACHED THE NAVIGATION REFERENCE ARRAY WITH IMAGING PHANTOM TO THE PELVIS. INTRAOPERATIVE 3D CONE BEAM CT SCAN WAS PERFORMED USING AN O-ARM. SURGEON VERIFIED THE AUTOMATIC REGISTRATION OF THE SCAN TO THE PATIENT ANATOMY AND JUDGED THE ACCURACY OF THE […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code SBF, in Neurology, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.