510(k) · Cleared
Recalled · Class II · 2019Neocis Guidance System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neocis, Inc. · PLV Dental Stereotaxic Instrument
Cleared on Dec 22, 2016 as substantially equivalent to K150222 (X-Nav Technologies, LLC, 2015) after a 216-day review. Its family tree reaches back 3 generations to 1999. 15 later devices descend from it. It has been recalled once.
- Decided
- Dec 22, 2016
- Review
- 216 days
- Class
- Class II
- Product code
- PLV
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K983831 (1999). 4 ancestors in all. 15 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 2 generations backK023424 Igi-SystemDenx Advanced Dental Systems · 2003
- 1 generation backK150222 X-Guide Surgical Navigation SystemX-Nav Technologies, LLC · 2015 · Recalled
- This deviceK161399 Neocis Guidance SystemNeocis, Inc. · 2016
- Descendant · cites it directly · 7 of its ownK202264 Neocis Guidance System (NGS) with Yomi Plan v2.0Neocis, Inc. · 2020
- Descendant · 2 generations on · 5 of its ownK210711 Neocis Guidance System (NGS) with Yomi Plan v2.0.1Neocis, Inc. · 2021
- Descendant · cites it directly · 5 of its ownK173402 Neocis Guidance System (NGS) with Chairside SplintNeocis, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 4 of its ownK222049 Yomi Robotic SystemNeocis, Inc. · 2022
- Descendant · 4 generations on · 3 of its ownK222750 Yomi Robotic SystemNeocis, Inc. · 2022
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K202264Neocis Guidance System (NGS) with Yomi Plan v2.0Neocis, Inc. · 2020 · cites it directly7descendants
- K210711Neocis Guidance System (NGS) with Yomi Plan v2.0.1Neocis, Inc. · 2021 · 2 generations on5descendants
- K173402Neocis Guidance System (NGS) with Chairside SplintNeocis, Inc. · 2018 · cites it directly5descendants
- K222049Yomi Robotic SystemNeocis, Inc. · 2022 · 3 generations on4descendants
- K222750Yomi Robotic SystemNeocis, Inc. · 2022 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −2 | K023424 | Igi-System | Denx Advanced Dental Systems | 2003 | — |
| −1 | K150222 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | 2015 | 1 |
| 0 (this device) | K161399 | Neocis Guidance System | Neocis, Inc. | 2016 | — |
| +1 | K202264 | Neocis Guidance System (NGS) with Yomi Plan v2.0 | Neocis, Inc. | 2020 | — |
| +2 | K210711 | Neocis Guidance System (NGS) with Yomi Plan v2.0.1 | Neocis, Inc. | 2021 | — |
| +1 | K173402 | Neocis Guidance System (NGS) with Chairside Splint | Neocis, Inc. | 2018 | 4 |
| +3 | K222049 | Yomi Robotic System | Neocis, Inc. | 2022 | — |
| +4 | K222750 | 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 |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K150222 | X-Guide Surgical Navigation SystemSummary page 4…g instrument and accessories (21 CFR 872.4120) Classification: Class II Product Code: PLV Predicate Device: X-Guide® Surgical Navigation System (K150222) as primary predicate, IGI System (K023424) as reference device Indications for Use: The Neocis Guidance System (NGS) is a compu… | 2015 |
| † | K023424 | Igi-System | 2003 |
What descends from it? (15)
See all 153 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 |
|---|---|---|---|---|
| Oct 4, 2019 | Class II | Z-0511-2020 | Process control | The Fiducial Array may mismatch their measurement files resulting in failed landmark check. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K202264 (Neocis, Inc., 2020) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K150222.
How does its category compare?
All PLV devicesPLV Dental Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161399 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161399: Neocis Guidance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161399
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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