510(k) · Cleared
ClearedIgi-System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Denx Advanced Dental Systems · HAW Neurological Stereotaxic Instrument
Cleared on May 9, 2003 as substantially equivalent to K003347 (Kinamed, Inc., 2001) and 1 other predicate after a 210-day review. Its family tree reaches back 1 generation to 1999. 29 later devices descend from it.
- Decided
- May 9, 2003
- Review
- 210 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K983831 (1999). 2 ancestors in all. 29 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK983831 VECTORVISION2Brainlab AG · 1999
- This deviceK023424 Igi-SystemDenx Advanced Dental Systems · 2003
- Descendant · cites it directly · 26 of its ownK150222 X-Guide Surgical Navigation SystemX-Nav Technologies, LLC · 2015 · Recalled
- Descendant · 2 generations on · 15 of its ownK161399 Neocis Guidance SystemNeocis, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 7 of its ownK202264 Neocis Guidance System (NGS) with Yomi Plan v2.0Neocis, Inc. · 2020
- Descendant · 4 generations on · 5 of its ownK210711 Neocis Guidance System (NGS) with Yomi Plan v2.0.1Neocis, Inc. · 2021
- Descendant · 3 generations on · 5 of its ownK173402 Neocis Guidance System (NGS) with Chairside SplintNeocis, Inc. · 2018 · Recalled
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K150222X-Guide Surgical Navigation SystemX-Nav Technologies, LLC · 2015 · cites it directly26descendants
- K161399Neocis Guidance SystemNeocis, Inc. · 2016 · 2 generations on15descendants
- K202264Neocis Guidance System (NGS) with Yomi Plan v2.0Neocis, Inc. · 2020 · 3 generations on7descendants
- K210711Neocis Guidance System (NGS) with Yomi Plan v2.0.1Neocis, Inc. · 2021 · 4 generations on5descendants
- K173402Neocis Guidance System (NGS) with Chairside SplintNeocis, Inc. · 2018 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| 0 (this device) | K023424 | Igi-System | Denx Advanced Dental Systems | 2003 | — |
| +1 | K150222 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | 2015 | 1 |
| +2 | K161399 | Neocis Guidance System | Neocis, Inc. | 2016 | 1 |
| +3 | K202264 | Neocis Guidance System (NGS) with Yomi Plan v2.0 | Neocis, Inc. | 2020 | — |
| +4 | K210711 | Neocis Guidance System (NGS) with Yomi Plan v2.0.1 | Neocis, Inc. | 2021 | — |
| +3 | K173402 | Neocis Guidance System (NGS) with Chairside Splint | Neocis, Inc. | 2018 | 4 |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2015 | 1 | 0 |
| 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 HAW? 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K003347 | OrthopilotSummary page 2…uant to 21 C.F.R. S; 882.4560 (product code HAW), and it is reviewed by the General & Plastic Surgery Advisory Committee. Predicate Devices: Orthopilot, by Kinamed Inc. (K003347), and Vectorvi:sion2, by BrainLab AG (K98383 1 ). Description of the Device: The IGI-System is an electro-optical device, which… | 2001 |
| * | K983831 | VECTORVISION2Summary page 2…W), and it is reviewed by the General & Plastic Surgery Advisory Committee. Predicate Devices: Orthopilot, by Kinamed Inc. (K003347), and Vectorvi:sion2, by BrainLab AG (K98383 1 ). Description of the Device: The IGI-System is an electro-optical device, which was specifically designed to greatly improve t… | 1999 |
What descends from it? (29)
See all 293 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?
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
The IGI-System.lbi, Image-Guided Implantation System, 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 accurate navigational guidance of surgical instruments, with regard to the pre-operative planpmg4.p dental implantation procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023424: Igi-System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023424
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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