510(k) · Cleared
ClearedZeta Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zeta Surgical, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on May 1, 2026 as substantially equivalent to K242351 (Zeta Surgical, Inc., 2024) and 2 other predicates after a 162-day review. Its family tree reaches back 8 generations to 2000.
- Decided
- May 1, 2026
- Review
- 162 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K993239 (2000). 15 ancestors in all, the oldest K992304 (1999). No later device cites it as a predicate yet.
- Root · 8 generations backK993239 Stryker Navigation System - Neuro Module, Model 6000-XXX-XXXStryker Corp. · 2000 · Recalled
- 7 generations backK062640 Stryker Navigation System - Cranial Module, Model 6000-650-000Stryker Instruments · 2006 · Recalled
- 6 generations backK142024 Brightmatter Navigation SystemSynaptive Medical, Inc. · 2015 · Recalled
- 5 generations backK181041 7D Surgical System Cranial Application7D Surgical, Inc. · 2018
- 4 generations backK192945 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement…7D Surgical, Inc. · 2019
- 3 generations backK230661 Zeta Cranial Navigation SystemZeta Surgical · 2023
- 2 generations backK233903 Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc. · 2024
- 1 generation backK242351 Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc. · 2024
- This deviceK253663 Zeta Navigation SystemZeta Surgical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K993239 | Stryker Navigation System - Neuro Module, Model 6000-XXX-XXX | Stryker Corp. | 2000 | 6 |
| −7 | K062640 | Stryker Navigation System - Cranial Module, Model 6000-650-000 | Stryker Instruments | 2006 | 19 |
| −6 | K142024 | Brightmatter Navigation System | Synaptive Medical, Inc. | 2015 | 1 |
| −5 | K181041 | 7D Surgical System Cranial Application | 7D Surgical, Inc. | 2018 | — |
| −4 | K192945 | 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application | 7D Surgical, Inc. | 2019 | — |
| −3 | K230661 | Zeta Cranial Navigation System | Zeta Surgical | 2023 | — |
| −2 | K233903 | Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical, Inc. | 2024 | — |
| −1 | K242351 | Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical, Inc. | 2024 | — |
| 0 (this device) | K253663 | Zeta Navigation System | Zeta Surgical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K242351 | Zeta Cranial Navigation System (ZNS131-US)Summary page 5…strument, 21 CFR 882.4560 Regulatory Class: Class II Product Code: HAW 3. PREDICATE DEVICE Zeta Navigation System [K242351] Medtronic Passive Planar Blunt Probe [K050438] Cranial Reducing Tubes [K162604] 4. DEVICE DESCRIPTION… | 2024 |
| * | K050438 | Stealthstation System UpdateSummary page 5…Class II Product Code: HAW 3. PREDICATE DEVICE Zeta Navigation System [K242351] Medtronic Passive Planar Blunt Probe [K050438] Cranial Reducing Tubes [K162604] 4. DEVICE DESCRIPTION The Zeta Navigation System is a stereotaxic, image… | 2005 |
| * | K162604 | Cranial Reducing TubesSummary page 5…HAW 3. PREDICATE DEVICE Zeta Navigation System [K242351] Medtronic Passive Planar Blunt Probe [K050438] Cranial Reducing Tubes [K162604] 4. DEVICE DESCRIPTION The Zeta Navigation System is a stereotaxic, image guided planning and intraoperative guida… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 6 companies; a new generation was cleared every 3.4 years on median.
- 6 of the 15 ancestors have a recall of any class.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Zeta Navigation System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The device is indicated only for cranial surgery where reference to a rigid anatomical structure can be identified, does not require rigid fixation of the patient, and does not require fixation of a navigated instrument guide to the patient. The system is intended to be used in operating…
Read the full statement (165 words)
The Zeta Navigation System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The device is indicated only for cranial surgery where reference to a rigid anatomical structure can be identified, does not require rigid fixation of the patient, and does not require fixation of a navigated instrument guide to the patient. The system is intended to be used in operating rooms and in less acute surgical settings such as interventional procedure suites.
The Zeta Stylet is intended to be used in conjunction only with the Zeta Navigation System to provide stereotaxic guidance for the placement and operation of catheters, shunts or similar products, and anatomy registration during cranial procedures.
The Zeta Bolt is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures performed in conjunction only with the Zeta Navigation System using preoperative MR and/or CT imaging. These procedures include brain biopsies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253663 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253663: Zeta Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253663
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026