510(k) · Cleared
ClearedZ Kat Flurotactic Guidance System Mki
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Z-Kat, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Jun 23, 1999 as substantially equivalent to K954276 (Surgical Navigation Technologies, Inc., 1996) and 3 other predicates after a 203-day review. Its family tree reaches back 4 generations to 1991. 152 later devices descend from it.
- Decided
- Jun 23, 1999
- Review
- 203 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K905070 (1991). 9 ancestors in all, the oldest K861692 (1986). 152 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 3 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 2 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 1 generation backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- This deviceK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- Descendant · cites it directly · 151 of its ownK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- Descendant · 2 generations on · 146 of its ownK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- Descendant · 2 generations on · 81 of its ownK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- Descendant · 3 generations on · 78 of its ownK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- Descendant · 3 generations on · 76 of its ownK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
Showing 5 of 152 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 152 · See all- K013025Modification to Flourolab PlusZ-Kat, Inc. · 2001 · cites it directly151descendants
- K031454Acumen Surgical Navigation SystemBiomet, Inc. · 2004 · 2 generations on146descendants
- K031337Acumen Surgical Navigation SystemBiomet, Inc. · 2003 · 2 generations on81descendants
- K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · 3 generations on78descendants
- K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · 3 generations on76descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −3 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −2 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −1 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| 0 (this device) | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| +1 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| +2 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| +2 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| +3 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| +3 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 11 | 0 |
| 2018 | 2 | 0 |
| 2019 | 10 | 0 |
| 2020 | 12 | 0 |
| 2021 | 9 | 0 |
| 2022 | 14 | 0 |
| 2023 | 20 | 0 |
| 2024 | 14 | 0 |
| 2025 | 18 | 0 |
| 2026 | 11 | 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? (4)
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 |
|---|---|---|---|
| * | K954276 | StealthstationSummary page 1…System Common name: Stereotaxic Instrument Classification name: Class II Substantial equivalence claimed to: StealthStation, Surgical Navigation Technologies, Inc., K954276 Radionics Operating Arm & OTS System/StereoPlan, K961844 Picker International Viewpoint System, K970604 Fischer Imaging AutoGuid… | 1996 |
| * | K961844 | Operating Arm System (Oas) [with CT and MR Images]Summary page 1…ion name: Class II Substantial equivalence claimed to: StealthStation, Surgical Navigation Technologies, Inc., K954276 Radionics Operating Arm & OTS System/StereoPlan, K961844 Picker International Viewpoint System, K970604 Fischer Imaging AutoGuide (Part of Mammotest Mammography Systern), K861692 Lalba… | 1996 |
| * | K970604 | Viewpoint - 3.0 SoftwareSummary page 1…med to: StealthStation, Surgical Navigation Technologies, Inc., K954276 Radionics Operating Arm & OTS System/StereoPlan, K961844 Picker International Viewpoint System, K970604 Fischer Imaging AutoGuide (Part of Mammotest Mammography Systern), K861692 Lalbadl ol e Description: The Fluorotactic Guidance… | 1997 |
| * | K861692 | Fischer PPS/Mammotest Mammography SystemSummary page 1…dionics Operating Arm & OTS System/StereoPlan, K961844 Picker International Viewpoint System, K970604 Fischer Imaging AutoGuide (Part of Mammotest Mammography Systern), K861692 Lalbadl ol e Description: The Fluorotactic Guidance System Mk. I is an integrated system that enables a surgeon to more accura… | 1986 |
What descends from it? (152)
See all 1521 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013025 | Modification to Flourolab Plus | 2001 | 151 |
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 8 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K013025 (Z-Kat, Inc., 2001) has gone furthest, with 151 descendants of its own.
- 22 other devices also cite its predicate K954276.
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 Fluorotactic Guidance System Mk. I will be used to assist in the accurate placement of a guiding device for surgery in which a linear trajectory insertion or placement is required. This system will use coordinated-fluoroscopy to allow intra-operative planning of the precise insertion point and angle of a device such as a screw, nail, or needle. The surgeon will place a registration artifact over the desired surgical area and capture two fluoroscopic…
Read the full statement (122 words)
The Fluorotactic Guidance System Mk. I will be used to assist in the accurate placement of a guiding device for surgery in which a linear trajectory insertion or placement is required. This system will use coordinated-fluoroscopy to allow intra-operative planning of the precise insertion point and angle of a device such as a screw, nail, or needle.
The surgeon will place a registration artifact over the desired surgical area and capture two fluoroscopic images, which will then be displayed on two computer screens. The surgeon will manipulate a virtual guidewire on the screens, until the desired angle and placement is achieved. The system will then output 3D coordinates to the robot arm which will move the drill guide to a precise position.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984298 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984298: Z Kat Flurotactic Guidance System Mki.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984298
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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