Neurology · 510(k) · 2024
xvision Spine System
Augmedics Ltd.. Cleared by FDA on 16 October 2024 under submission K241481, product code SBF (orthopedic augmented reality). What FDA's record says, in FDA's words.
Device record · K241481
- Device. xvision Spine SystemDEVICE
- Company. Augmedics Ltd. (IL)COMPANY
- Decision. 16 October 2024, 510(k), substantially equivalent (traditional review); received 24 May 2024DECISION
- Panel. NeurologyPANEL
- Product code. SBF, Orthopedic Augmented RealityCODE
- Regulation. 21 CFR 882.4560, Class IIREG
- Source. FDA database entry · decision document (12 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.
The xvision Spine System, with xvision Spine System Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to a patient’s fluoroscopic or CT imagery of the anatomy. This can include the following spinal procedures: - Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region. - Posterior Screw Placement in C3-C7 vertebrae - Iliosacral Screw Placement - Angular procedures requiring access to the disc space - Lateral trajectories required to access the Sacro-Iliac joint The Headset of the xvision Spine System displays 2D stereotaxic screens and a virtual anatomy screen. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient imagery. The virtual screen is indicated for displaying the virtual instrument location in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning. The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.
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.
- Modalities namedCT
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, from Augmedics Ltd., or cleared in 2024. 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.