510(k) · Cleared
Recalled · Class II · 2016X-Guide Surgical Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
X-Nav Technologies, LLC · PLV Dental Stereotaxic Instrument
Cleared on Oct 8, 2015 as substantially equivalent to K023424 (Denx Advanced Dental Systems, 2003) after a 251-day review. Its family tree reaches back 2 generations to 1999. 26 later devices descend from it. It has been recalled once.
- Decided
- Oct 8, 2015
- Review
- 251 days
- Class
- Class II
- Product code
- PLV
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K983831 (1999). 3 ancestors in all. 26 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 1 generation backK023424 Igi-SystemDenx Advanced Dental Systems · 2003
- This deviceK150222 X-Guide Surgical Navigation SystemX-Nav Technologies, LLC · 2015
- Descendant · cites it directly · 15 of its ownK161399 Neocis Guidance SystemNeocis, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 7 of its ownK202264 Neocis Guidance System (NGS) with Yomi Plan v2.0Neocis, Inc. · 2020
- Descendant · 3 generations on · 5 of its ownK210711 Neocis Guidance System (NGS) with Yomi Plan v2.0.1Neocis, Inc. · 2021
- Descendant · 2 generations on · 5 of its ownK173402 Neocis Guidance System (NGS) with Chairside SplintNeocis, Inc. · 2018 · Recalled
- Descendant · 4 generations on · 4 of its ownK222049 Yomi Robotic SystemNeocis, Inc. · 2022
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K161399Neocis Guidance SystemNeocis, Inc. · 2016 · cites it directly15descendants
- K202264Neocis Guidance System (NGS) with Yomi Plan v2.0Neocis, Inc. · 2020 · 2 generations on7descendants
- K210711Neocis Guidance System (NGS) with Yomi Plan v2.0.1Neocis, Inc. · 2021 · 3 generations on5descendants
- K173402Neocis Guidance System (NGS) with Chairside SplintNeocis, Inc. · 2018 · 2 generations on5descendants
- K222049Yomi Robotic SystemNeocis, Inc. · 2022 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −1 | K023424 | Igi-System | Denx Advanced Dental Systems | 2003 | — |
| 0 (this device) | K150222 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | 2015 | — |
| +1 | K161399 | Neocis Guidance System | Neocis, Inc. | 2016 | 1 |
| +2 | K202264 | Neocis Guidance System (NGS) with Yomi Plan v2.0 | Neocis, Inc. | 2020 | — |
| +3 | K210711 | Neocis Guidance System (NGS) with Yomi Plan v2.0.1 | Neocis, Inc. | 2021 | — |
| +2 | K173402 | Neocis Guidance System (NGS) with Chairside Splint | Neocis, Inc. | 2018 | 4 |
| +4 | K222049 | Yomi Robotic System | Neocis, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 0 |
| 2021 | 2 | 0 |
| 2022 | 6 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PLV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PLV device
- #1 K231018 Yomi Robotic Systemscore 13.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023424 | Igi-SystemSummary page 4…oduct Code: PLV (Dental Stereotaxic Instrument) Predicate Device(s): IGI-SystemTM by DENX Advanced Dental Systems Ltd. (K023424) 1555 Bustard Road, Suite #75, Landsdale, PA 19446 / 267-436-0420 / www.X-NavTech.com Device Descrip… | 2003 |
What descends from it? (26)
See all 266 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 23, 2016 | Class II | Z-1391-2016 | Nonconforming Material/Component | The X-Guide system utilizes an X-Clip (PN P007665) which contains fiducials to assist with registration of the patient anatomy. The X-Clip is a device worn intraorally by a patient during the CT scan and guided surgery procedures. The… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 12.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K161399 (Neocis, Inc., 2016) has gone furthest, with 15 descendants of its own.
- 2 other devices also cite its predicate K023424.
How does its category compare?
All PLV devicesPLV Dental Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PLV
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PLV
399in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PLV
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PLV
6in 2025
MAUDE reports naming product code PLV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 2 | — | 1 | 3 |
| 2020 | 7 | 86 | 1 | 0 |
| 2021 | 2 | — | 0 | 11 |
| 2022 | 3 | 399 | 0 | 39 |
| 2023 | 1 | — | 0 | 15 |
| 2024 | 1 | — | 0 | 9 |
| 2025 | 2 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The X-Guide(R) Surgical Navigation System is a computerized navigational system intended to provide assistance in both the
preoperative planning phase and intra-operative surgical phase of dental implantation procedures.
The system provides software to preoperatively plan dental implantation 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 require dental
implants as part of their treatment plan.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150222 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150222: X-Guide Surgical Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150222
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026