510(k) · Cleared
ClearedNeocis Guidance System (NGS) with Yomi Plan v2.0
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 4, 2020 as substantially equivalent to K161399 (Neocis, Inc., 2016) after a 115-day review. Its family tree reaches back 4 generations to 1999. 7 later devices descend from it.
- Decided
- Dec 4, 2020
- Review
- 115 days
- Class
- Class II
- Product code
- PLV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K983831 (1999). 5 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 3 generations backK023424 Igi-SystemDenx Advanced Dental Systems · 2003
- 2 generations backK150222 X-Guide Surgical Navigation SystemX-Nav Technologies, LLC · 2015 · Recalled
- 1 generation backK161399 Neocis Guidance SystemNeocis, Inc. · 2016 · Recalled
- This deviceK202264 Neocis Guidance System (NGS) with Yomi Plan v2.0Neocis, Inc. · 2020
- Descendant · cites it directly · 5 of its ownK210711 Neocis Guidance System (NGS) with Yomi Plan v2.0.1Neocis, Inc. · 2021
- Descendant · 2 generations on · 4 of its ownK222049 Yomi Robotic SystemNeocis, Inc. · 2022
- Descendant · 3 generations on · 3 of its ownK222750 Yomi Robotic SystemNeocis, Inc. · 2022
- Descendant · 4 generations on · 2 of its ownK231018 Yomi Robotic SystemNeocis, Inc. · 2023
- Descendant · 5 generations on · 0 of its ownK252376 Yomi S Robotic SystemNeocis, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K210711Neocis Guidance System (NGS) with Yomi Plan v2.0.1Neocis, Inc. · 2021 · cites it directly5descendants
- K222049Yomi Robotic SystemNeocis, Inc. · 2022 · 2 generations on4descendants
- K222750Yomi Robotic SystemNeocis, Inc. · 2022 · 3 generations on3descendants
- K231018Yomi Robotic SystemNeocis, Inc. · 2023 · 4 generations on2descendants
- K252376Yomi S Robotic SystemNeocis, Inc. · 2025 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −3 | K023424 | Igi-System | Denx Advanced Dental Systems | 2003 | — |
| −2 | K150222 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | 2015 | 1 |
| −1 | K161399 | Neocis Guidance System | Neocis, Inc. | 2016 | 1 |
| 0 (this device) | K202264 | Neocis Guidance System (NGS) with Yomi Plan v2.0 | Neocis, Inc. | 2020 | — |
| +1 | K210711 | Neocis Guidance System (NGS) with Yomi Plan v2.0.1 | Neocis, Inc. | 2021 | — |
| +2 | K222049 | Yomi Robotic System | Neocis, Inc. | 2022 | — |
| +3 | K222750 | Yomi Robotic System | Neocis, Inc. | 2022 | — |
| +4 | K231018 | Yomi Robotic System | Neocis, Inc. | 2023 | — |
| +5 | K252376 | Yomi S Robotic System | Neocis, Inc. | 2025 | — |
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 |
|---|---|---|
| 2021 | 1 | 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 |
|---|---|---|---|
| * | K161399 | Neocis Guidance SystemSummary page 4…Class II Product Code: PLV III. Predicate Devices • Primary Predicate: o Neocis Guidance System (NGS) (K161399) • Reference Devices o Neocis Planning Software Application for 3rd Party PCs (K191363)… | 2016 |
| † | K191363 | Neocis Planning Software Application (NPSA) for 3rd Party PCs | 2019 |
| † | K200805 | Neocis Guidance System (NGS) with Patient Splints | 2020 |
What descends from it? (7)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K210711 (Neocis, Inc., 2021) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K161399.
How does its category compare?
All PLV devicesPLV Dental Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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. The NGS is intended for use in partially edentulous and fully edentulous adult patients who…
Read the full statement (114 words)
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. The NGS is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.
When Yomi Plan software is used for preplanning on third party PCs, it is intended to perform the planning (pre-operative) phase of dental implantation surgery. Yomi Plan provides pre-operative planning for dental implantation procedures. The output of Yomi Plan is to be used with the Neocis Guidance System (NGS).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202264 · printed Nov 5, 2026
Cite this page
510(k) Report. “K202264: Neocis Guidance System (NGS) with Yomi Plan v2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K202264
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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