510(k) · Cleared
ClearedModification to Flourolab Plus
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 Oct 3, 2001 as substantially equivalent to K984298 (Z-Kat, Inc., 1999) and 4 other predicates after a 23-day review. Its family tree reaches back 5 generations to 1991. 151 later devices descend from it.
- Decided
- Oct 3, 2001
- Review
- 23 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K905070 (1991). 13 ancestors in all, the oldest K861692 (1986). 151 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 4 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 3 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 2 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 1 generation backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- This deviceK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- Descendant · cites it directly · 146 of its ownK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- Descendant · cites it directly · 81 of its ownK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- Descendant · 2 generations on · 78 of its ownK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- Descendant · 2 generations on · 76 of its ownK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- Descendant · 2 generations on · 71 of its ownK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
Showing 5 of 151 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 151 · See all- K031454Acumen Surgical Navigation SystemBiomet, Inc. · 2004 · cites it directly146descendants
- K031337Acumen Surgical Navigation SystemBiomet, Inc. · 2003 · cites it directly81descendants
- K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · 2 generations on78descendants
- K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · 2 generations on76descendants
- K111863Signature Planner,Signature GuidesMaterialise NV · 2012 · 2 generations on71descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −4 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −3 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −2 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −1 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| 0 (this device) | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| +1 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| +1 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| +2 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| +2 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
| +2 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
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 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K984298 | Z Kat Flurotactic Guidance System MkiSummary page 1…Lab Plus COMMON NAME: Stereotaxic Instrument CLASSIFICATION NAME: Class II SUBSTANTIAL EQUIVALENCE CLAIMED TO: 1. The Fluorotactic Guidance System, Mk I, Z-KAT, Inc., K984298 2. StealthStation, Sofamor Danek, K954276 3. FluoroNav, Sofamor Danek, K990214 4. The Voyager; Marconi Medical Systems, K00031… | 1999 |
| * | K954276 | StealthstationSummary page 1…nt CLASSIFICATION NAME: Class II SUBSTANTIAL EQUIVALENCE CLAIMED TO: 1. The Fluorotactic Guidance System, Mk I, Z-KAT, Inc., K984298 2. StealthStation, Sofamor Danek, K954276 3. FluoroNav, Sofamor Danek, K990214 4. The Voyager; Marconi Medical Systems, K000310 5. VectorVision?, BrainLab, K962939 DESC… | 1996 |
| * | K990214 | Fluoronav Module for the Stealthstation SystemSummary page 1…STANTIAL EQUIVALENCE CLAIMED TO: 1. The Fluorotactic Guidance System, Mk I, Z-KAT, Inc., K984298 2. StealthStation, Sofamor Danek, K954276 3. FluoroNav, Sofamor Danek, K990214 4. The Voyager; Marconi Medical Systems, K000310 5. VectorVision?, BrainLab, K962939 DESCRIPTION: FluoroLab Plus is an integra… | 1999 |
| * | K000310 | Voyager 6.0 Software OptionSummary page 1…ic Guidance System, Mk I, Z-KAT, Inc., K984298 2. StealthStation, Sofamor Danek, K954276 3. FluoroNav, Sofamor Danek, K990214 4. The Voyager; Marconi Medical Systems, K000310 5. VectorVision?, BrainLab, K962939 DESCRIPTION: FluoroLab Plus is an integrated system that helps a surgeon more accurately po… | 2000 |
| * | K962939 | VectorvisionSummary page 1…., K984298 2. StealthStation, Sofamor Danek, K954276 3. FluoroNav, Sofamor Danek, K990214 4. The Voyager; Marconi Medical Systems, K000310 5. VectorVision?, BrainLab, K962939 DESCRIPTION: FluoroLab Plus is an integrated system that helps a surgeon more accurately position drill guides, screw drivers,… | 1997 |
What descends from it? (151)
See all 1513 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 10 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K031454 (Biomet, Inc., 2004) has gone furthest, with 146 descendants of its own.
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?
FluoroLab Plus will be used to assist in the alignment of surgical instruments by providing the surgeon with intraoperative navigational guidance based on pre-acquired fluoroscopic images. This system will use coordinated-fluoroscopy to allow intra-operative planning of the alignment of surgical tools such as a screw, nail, or needle.
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/K013025 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013025: Modification to Flourolab Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013025
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026