510(k) · Cleared
ClearedGeniant Cranial (Navigated Neurosurgical Positioning Robot)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Koh Young Technology, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Jan 17, 2025 as substantially equivalent to K200511 (Medtech S.A, 2020) and 1 other predicate after a 252-day review. Its family tree reaches back 10 generations to 2000. 7 of the 31 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Jan 17, 2025
- Review
- 252 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K002053 (2000). 29 ancestors in all, the oldest K811452 (1981). 1 later device descends from it, 1 citing it directly. 7 of the 31 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 6 generations between
- 3 generations backK172444 ROSA BRAIN (v3.0.0.5)Medtech S.A · 2018 · Recalled (Class I)
- 2 generations backK182417 ROSA ONE Brain ApplicationMedtech S.A · 2019 · Recalled (Class I)
- 1 generation backK200511 ROSA ONE Brain applicationMedtech S.A · 2020 · Recalled (Class I)
- This deviceK241333 Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK253856 Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 9 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 8 generations backK043536 Navitrack System - S&N Image Free KneeOrthosoft, Inc. · 2005
- 7 generations backK060556 Brigit Surgical DeviceZimmer, Inc. · 2006
- 6 generations backK092239 Rosa Surgical Device, Model Rosa 1.1Medtech S.A · 2009 · Recalled
- 5 generations backK101791 Rosa Surgical DeviceMedtech S.A.S · 2010 · Recalled
- 4 generations backK151359 ROSA BrainMedtech S.A · 2015 · Recalled (Class I)
- 3 generations backK172444 ROSA BRAIN (v3.0.0.5)Medtech S.A · 2018 · Recalled (Class I)
- 2 generations backK182417 ROSA ONE Brain ApplicationMedtech S.A · 2019 · Recalled (Class I)
- 1 generation backK200511 ROSA ONE Brain applicationMedtech S.A · 2020 · Recalled (Class I)
- This deviceK241333 Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc. · 2025
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −9 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −8 | K043536 | Navitrack System - S&N Image Free Knee | Orthosoft, Inc. | 2005 | — |
| −7 | K060556 | Brigit Surgical Device | Zimmer, Inc. | 2006 | — |
| −6 | K092239 | Rosa Surgical Device, Model Rosa 1.1 | Medtech S.A | 2009 | 9 |
| −5 | K101791 | Rosa Surgical Device | Medtech S.A.S | 2010 | 12 |
| −4 | K151359 | ROSA Brain | Medtech S.A | 2015 | Class I |
| −3 | K172444 | ROSA BRAIN (v3.0.0.5) | Medtech S.A | 2018 | Class I |
| −2 | K182417 | ROSA ONE Brain Application | Medtech S.A | 2019 | Class I |
| −1 | K200511 | ROSA ONE Brain application | Medtech S.A | 2020 | Class I |
| 0 (this device) | K241333 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. | 2025 | — |
| +1 | K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 1 |
| 2017 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
7 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K200511 | ROSA ONE Brain applicationSummary page 5…s): HAW Class: II Classification Panel: Neurology 4. Legally Marketed Predicate Device(s) Primary Device name: ROSA ONE Brain Application 510(k) number: K200511 Manufacturer: Medtech S.A Secondary Device name: StealthStation S8 System Platforms and StealthStation Cranial Software… | 2020 |
| * | K162309 | StealthStation S8 System Platforms and StealthStation Cranial SoftwareSummary page 5…10(k) number: K200511 Manufacturer: Medtech S.A Secondary Device name: StealthStation S8 System Platforms and StealthStation Cranial Software 510(k) number: K162309 Manufacturer: Medtronic Navigation, Inc. 5. Device Description Geniant Cranial is a hardware platform that supports real-… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | 2026 | 0 |
Has anything in its family been recalled? (7 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K200511ROSA ONE Brain applicationMedtech S.A · 2020 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 2017 · Direct predicate · ◆ in the 2017 ancestors bar of FIG. 12 Class I recalls
- K182417ROSA ONE Brain ApplicationMedtech S.A · 2019 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 2 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K172444ROSA BRAIN (v3.0.0.5)Medtech S.A · 2018 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 3 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
- K151359ROSA BrainMedtech S.A · 2015 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 13 of the 29 ancestors have a recall of any class; 7 have a Class I recall.
- Of its descendants, K253856 (Koh Young Technology, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K200511.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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 device is intended to aid in locating anatomical structures and for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons for navigating and guiding compatible surgical instruments in open or percutaneous procedures. The device is indicated for any neurosurgical procedure in which stereotactic neurosurgery may be appropriate and where reference to a rigid anatomical structure, such as the skull, can be identified relative to anatomy images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241333 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241333: Geniant Cranial (Navigated Neurosurgical Positioning Robot).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241333
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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