Dental · 510(k) · 2024
X-Guide Surgical Navigation System
X-Nav Technologies, LLC. Cleared by FDA on 21 February 2024 under submission K232148, product code QRY (dental navigation system). What FDA's record says, in FDA's words.
Device record · K232148
- Device. X-Guide Surgical Navigation SystemDEVICE
- Company. X-Nav Technologies, LLCCOMPANY
- Decision. 21 February 2024, 510(k), substantially equivalent (traditional review); received 19 July 2023DECISION
- Panel. DentalPANEL
- Product code. QRY, Dental Navigation SystemCODE
- Regulation. 21 CFR 872.4120, Class IIREG
- Source. FDA database entry · decision document (22 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 X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures and/or endodontic access procedures. The system provides software to preoperatively plan dental implantation procedures and/or endodontics access procedures and provides navigational guidance of the surgical instruments. The device is intended for use for partially edentulous and edentulous adult and geriatric patients who need dental implants as a part of their treatment plan. The device is also intended for endodontic access procedures (i.e., apicoectomies and/or access of calcified canals) where a CBCT is deemed appropriate as part of their treatment plan.
The product code's definition, from FDA's classification record. Intended to provide real-time guidance on the orientation and location of the dental instrument relative to the patient's anatomy for general dentistry procedures.
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.
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 9 reports filed against devices carrying product code QRY. 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:
13 November 2024 · Malfunction · X-GUIDE SURGICAL NAVIGATION SYSTEM · X-NAV TECHNOLOGIES, LLC · report 3011764595-2024-00001
OFFICE CALLED AND SAID SOMETHING "SNAPPED" IN ONE THE HINGES WITHIN THE BOOM ARM DURING SURGERY AND THE NAVIGATION ASSEMBLY PARTIALLY DROPPED AND HIT THE DOCTOR. DOCTOR IS PHYSICALLY OKAY. OFFICE WILL CALL BACK WHEN THE MACHINE IS AVAILABLE TO TAKE PICTURES AND ASSESS THE DAMAGE, SO TECHNICAL SUPPORT CAN DETERMINE HOW TO MOVE FORWARD WITH THE REPAIR. CAMERAS AND LIGHTS ARE STILL FUNCTIONAL. PATIENT WAS NOT INVOLVED.
23 February 2024 · Injury · YOMI GUIDED DENTAL IMPLANT ROBOT · NEOCIS INC · report MW5151999
I WAS USING THE YOMI ROBOT TO PLACE DENTAL IMPLANTS ON A SEDATED PATIENT UNDER THE SUPERVISION OF THE COMPANY TRAINOR. THE ROBOT ARM WAS ATTACHED TO THE PATIENT'S ANTERIOR MAXILLA WITH FOUR 3/4-INCH STRYKER SURGICAL SCREWS. THE SURGERY WAS GOING AS PLANNED WHEN THE ROBOT VERY QUICKLY AND VIOLENTLY LIFTED MY PATIENT'S HEAD OFF THE REST AND SLAMMED IT DOWN AND PINNED IT AGAINST THE CHAIR EIGHT INCHES TO THE LEFT OF THE ORIGINAL POSITION. I WAS UNABLE TO MOVE THE ARM OR THE PATIENT'S HEAD. THE […]
13 November 2023 · Injury · YOMI ROBOTIC SYSTEM · NEOCIS, INC. · report 3012787974-2023-80079
AFTER A GUIDED PROCEDURE, IT WAS FOUND THAT 1 OF 2 IMPLANT PLACEMENTS PARTIALLY COMPROMISED THE BUCCAL WALL. A POST OPERATIVE ASSESSMENT WITH THE SYSTEM'S LOG FILES WAS COMPLETED. A SLIGHT HANDPIECE ROTATION WAS DETERMINED TO BE THE LIKELY ROOT CAUSE OF THE EVENT AS IT WOULD EXPLAIN THE 1.0 MM ERROR DURING THE LANDMARK CHECK AND ALSO WHY PART OF THE IMPLANT WAS OUTSIDE THE BUCCAL WALL. THE SURGEON REMOVED THE IMPLANT AND REPLACED IT. THERE WERE NO FURTHER ISSUES NOTED WITH THE REPLACED IMPLANT […]
6 November 2023 · Injury · YOMI ROBOTIC SYSTEM · NEOCIS, INC. · report 3012787974-2023-80078
AFTER A GUIDED PROCEDURE, IT WAS FOUND THAT 1 OF 2 IMPLANT PLACEMENTS WERE NOT ACCORDING TO THE SURGICAL PLAN. ONE IMPLANT WAS PLACED BUCCAL TO PLAN. AN ANALYSIS OF THE SYSTEM LOG FILES AND A POST-OP CT SCAN WAS COMPLETED. SOME CONTRIBUTING FACTORS WERE IDENTIFIED I.E., PATIENT WAS OUTSIDE OF THE RECOMMENDED WORK VOLUME, HOWEVER A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. A QUICK CHECK OF THE SYSTEM WAS ALSO PERFORMED AFTER THE PROCEDURE AND THE SYSTEM WAS FOUND TO BE IN GOOD WORKING […]
5 November 2023 · Injury · YOMI ROBOTIC SYSTEM · NEOCIS, INC. · report 3012787974-2023-80077
AFTER A GUIDED PROCEDURE, IT WAS FOUND THAT THE IMPLANT PLACEMENT WAS NOT ACCORDING TO THE SURGICAL PLAN. BASED ON AN ANALYSIS OF THE SYSTEM LOG FILES, IT WAS FOUND THAT THE SYSTEM WAS USED OFF LABEL. SPECIFICALLY, THE SPLINT USED REQUIRES A MINIMUM OF 3 BONE SCREWS TO ENSURE ACCURATE TRACKING OF PATIENT MOVEMENT, HOWEVER THE SURGEON USED ONLY 2 BONE SCREWS. ALTHOUGH THE SPLINT SEEMED STABLE DURING THE PROCEDURE PER FEEDBACK FROM THE FIELD, LIKELY ROOT CAUSE OF THIS EVENT IS SPLINT MOVEMENT […]
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 QRY, in Dental, 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.