510(k) · Cleared
Recalled · Class II · 2026Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · HAW Neurological Stereotaxic Instrument
Cleared on Feb 16, 2023 as substantially equivalent to K212397 (Medtronic Navigation, 2021) and 4 other predicates after a 582-day review. Its family tree reaches back 7 generations to 2005. 4 of the 21 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Feb 16, 2023
- Review
- 582 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 7 generations to K050438 (2005). 19 ancestors in all, the oldest K971247 (1997). 1 later device descends from it, 1 citing it directly. 4 of the 21 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
- 6 generations backK150216 Synergy CranialMedtronic Navigation, Inc. · 2015 · Recalled (Class I)
- 5 generations backK153660 StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · Recalled (Class I)
- 4 generations backK162309 StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 2017 · Recalled (Class I)
- 3 generations backK201175 StealthStation Cranial Software v1.3.0Medtronic Navigation, Inc. · 2020
- 2 generations backK203639 StealthStation Cranial Software v1.3.2Medtronic Navigation, Inc. · 2021
- 1 generation backK212397 StealthStation S8 Cranial v2.0Medtronic Navigation · 2021 · Recalled (Class I)
- This deviceK212194 Stryker Q Guidance System with Cranial Guidance Software…Stryker Corporation · 2023
- Descendant · cites it directly · 0 of its ownK233542 Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee…Stryker Leibinger GmbH & Co KG · 2024
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K233542Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho…Stryker Leibinger GmbH & Co KG · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K050438 | Stealthstation System Update | Medtronic Surgical Navigation Technologies | 2005 | 11 |
| −6 | K150216 | Synergy Cranial | Medtronic Navigation, Inc. | 2015 | Class I |
| −5 | K153660 | StealthStation System with Cranial Software | Medtronic Navigation, Inc. | 2016 | Class I |
| −4 | K162309 | StealthStation S8 System Platforms and StealthStation Cranial Software | Medtronic Navigation, Inc. | 2017 | Class I |
| −3 | K201175 | StealthStation Cranial Software v1.3.0 | Medtronic Navigation, Inc. | 2020 | — |
| −2 | K203639 | StealthStation Cranial Software v1.3.2 | Medtronic Navigation, Inc. | 2021 | — |
| −1 | K212397 | StealthStation S8 Cranial v2.0 | Medtronic Navigation | 2021 | Class I |
| 0 (this device) | K212194 | Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker… | Stryker Corporation | 2023 | — |
| +1 | K233542 | Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software… | Stryker Leibinger GmbH & Co KG | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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.
4 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? (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 |
|---|---|---|---|
| * | K212397 | StealthStation S8 Cranial v2.0 Cleared while this submission was under review Summary page 9…StealthStation S8 Cranial Software v2.0 Stealth K212397 Tractography Medtronic StealthStationTM S8 System Platform… | 2021 |
| * | K162309 | StealthStation S8 System Platforms and StealthStation Cranial SoftwareSummary page 9…K212397 Tractography Medtronic StealthStationTM S8 System Platform K162309 Predicate Device Premarket Notification # CranialMask Tracker K162929… | 2017 |
| * | K162929 | Stryker Navigation System with CranialMap software application, Stryker CranialMap…Summary page 9…onic StealthStationTM S8 System Platform K162309 Predicate Device Premarket Notification # CranialMask Tracker K162929 Stylet, 23 cm K141833… | 2017 |
| * | K141833 | Stylet, 23CM, Skull-Mount Patient Tracker, Non-Invasive Patient Tracker, Tracer Pointer…Summary page 9…n # CranialMask Tracker K162929 Stylet, 23 cm K141833 MDT Navigable Brain Biopsy Cannula K143241 Predicate Device Classification… | 2015 |
| * | K143241 | MDT Navigable Brain Biopsy CannulaSummary page 9…Stylet, 23 cm K141833 MDT Navigable Brain Biopsy Cannula K143241 Predicate Device Classification Regulation: 21 CFR 882.4560 3B & Name… | 2015 |
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 |
|---|---|---|---|
| K233542 | Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho… | 2024 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 24, 2026 | Not classified | Z-0314-2027 | Process control | Device may fracture during use at the laser welded joint on the pointer tube. If this happens, loose parts may fall out of the product while the device is inside the patient. |
| Nov 12, 2025 | Class II | Z-0963-2026 | Under Investigation by firm | When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the 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.
- K212397StealthStation S8 Cranial v2.0Medtronic Navigation · 2021 · 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 · ◆ on the line of descent in FIG. 12 Class I recalls
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 3 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 12 of the 19 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K233542 (Stryker Leibinger GmbH & Co KG, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K212397.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Stryker Q Guidance System, with the Cranial Guidance Software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer-assisted surgery. The system is indicated for any medical condition in which the use of computer-assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The system assists in…
Read the full statement (505 words)
The Stryker Q Guidance System, with the Cranial Guidance Software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer-assisted surgery.
The system is indicated for any medical condition in which the use of computer-assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The system assists in the positioning of instruments for cranial procedures, including:
- Cranial biopsies
- Craniotomies
- Craniectomies
- Resection of tumors and other lesions
- Skull base procedures
- Transnasal neurosurgical procedures
- Transphenoidal pituitary surgery
- Craniofacial procedures
- Skull reconstruction procedures
- Orbital cavity reconstruction procedures
- General ventricular catheter and shunt placement
- Pediatric ventricular catheter and shunt placement
The Q Guidance System is intended as an aid for precisely locating anatomical structures in open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate and where reference to a rigid anatomical structure such as the skull, vertebra, or long bone can be identified.
The Stryker CranialMask Tracker is intended to be used as an accessory to the CranialMap and the Cranial Guidance software applications. It is intended to be placed on the patient’s facial skin and used in combination with preoperative and intraoperative imaging devices to enable automatic patient registration for open or percutaneous computer-assisted surgery. The Stryker CranialMask Tracker can be used as a noninvasive patient tracker to support open or percutaneous cranial neurosurgical procedures.
The Stryker EM Stylet is indicated for use as an accessory to the Q Guidance System when used with the Cranial Guidance Software and electromagnetic navigation. It is indicated for use in locating anatomical structures during navigated cranial procedures.
The system is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
The EM Stylet is indicated for use in the following procedures:
* General ventricular catheter and shunt placement
* Pediatric ventricular catheter and shunt placement
The Stryker Navigated Biopsy Needle is intended to be used as an accessory to the Stryker Q Guidance System when used with the Cranial Guidance Software. It is a side cutting cannula where the cutting action is achieved by rotation of an inner cannula within an outer cannula for use in the stereotaxic biopsy of cranial tissue.
The Stryker Navigated Biopsy Needle may be used as part of the Stryker Cranial Guidance System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
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/K212194 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212194: Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212194
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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