510(k) · Cleared
ClearedVoyager Linux
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 Dec 20, 2002 as substantially equivalent to K000310 (Philips Medical Systems (Cleveland), Inc., 2000) after an 18-day review. Its family tree reaches back 1 generation to 2000. 172 later devices descend from it.
- Decided
- Dec 20, 2002
- Review
- 18 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000310 (2000). 172 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK000310 Voyager 6.0 Software OptionPhilips Medical Systems (Cleveland), Inc. · 2000
- This deviceK023975 Voyager LinuxZ-Kat, Inc. · 2002
- Descendant · cites it directly · 146 of its ownK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- Descendant · cites it directly · 97 of its ownK050973 Modification to: Voyager LinuxMako Surgical Corp. · 2005
- Descendant · 2 generations on · 96 of its ownK052851 Voyager Linux with Tactile Guidance System (TGS)Mako Surgical Corp. · 2005
- 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
Showing 5 of 172 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 172 · See all- K031454Acumen Surgical Navigation SystemBiomet, Inc. · 2004 · cites it directly146descendants
- K050973Modification to: Voyager LinuxMako Surgical Corp. · 2005 · cites it directly97descendants
- K052851Voyager Linux with Tactile Guidance System (TGS)Mako Surgical Corp. · 2005 · 2 generations on96descendants
- K031337Acumen Surgical Navigation SystemBiomet, Inc. · 2003 · cites it directly81descendants
- K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · 2 generations on78descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000310 | Voyager 6.0 Software Option | Philips Medical Systems (Cleveland), Inc. | 2000 | — |
| 0 (this device) | K023975 | Voyager Linux | Z-Kat, Inc. | 2002 | — |
| +1 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| +1 | K050973 | Modification to: Voyager Linux | Mako Surgical Corp. | 2005 | — |
| +2 | K052851 | Voyager Linux with Tactile Guidance System (TGS) | Mako Surgical Corp. | 2005 | — |
| +1 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| +2 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 4 | 0 |
| 2015 | 7 | 0 |
| 2016 | 7 | 0 |
| 2017 | 12 | 0 |
| 2018 | 3 | 0 |
| 2019 | 12 | 0 |
| 2020 | 14 | 0 |
| 2021 | 10 | 0 |
| 2022 | 14 | 0 |
| 2023 | 20 | 0 |
| 2024 | 14 | 0 |
| 2025 | 18 | 0 |
| 2026 | 12 | 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? (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 |
|---|---|---|---|
| * | K000310 | Voyager 6.0 Software Option | 2000 |
What descends from it? (172)
See all 1725 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 Voyager is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures. The Voyager is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such…
Read the full statement (105 words)
The Voyager is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.
The Voyager is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as:
Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous)
Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms
ENT procedures
Orthopedic surgical procedures
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/K023975 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023975: Voyager Linux.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023975
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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