510(k) · Cleared
ClearedStryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker
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 22, 2017 as substantially equivalent to K131214 (Stryker Corporate, 2013) after a 126-day review. Its family tree reaches back 3 generations to 2000. 3 later devices descend from it.
- Decided
- Feb 22, 2017
- Review
- 126 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K993239 (2000). 5 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK993239 Stryker Navigation System - Neuro Module, Model 6000-XXX-XXXStryker Corp. · 2000 · Recalled
- 2 generations backK062640 Stryker Navigation System - Cranial Module, Model 6000-650-000Stryker Instruments · 2006 · Recalled
- 1 generation backK131214 Cranial Map NeuroStryker Corporate · 2013
- This deviceK162929 Stryker Navigation System with CranialMap software application…Stryker Corporation · 2017
- Descendant · cites it directly · 1 of its ownK212194 Stryker Q Guidance System with Cranial Guidance Software…Stryker Corporation · 2023 · Recalled
- Descendant · 2 generations on · 0 of its ownK233542 Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee…Stryker Leibinger GmbH & Co KG · 2024
- Descendant · cites it directly · 0 of its ownK223288 Cranial Navigation, Navigation Software Cranial, Navigation Software…Brainlab AG · 2023
Most influential descendants
Showing 3 of 3 · See all- K212194Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and…Stryker Corporation · 2023 · cites it directly1descendant
- K233542Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho…Stryker Leibinger GmbH & Co KG · 2024 · 2 generations on0descendants
- K223288Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial…Brainlab AG · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K993239 | Stryker Navigation System - Neuro Module, Model 6000-XXX-XXX | Stryker Corp. | 2000 | 6 |
| −2 | K062640 | Stryker Navigation System - Cranial Module, Model 6000-650-000 | Stryker Instruments | 2006 | 19 |
| −1 | K131214 | Cranial Map Neuro | Stryker Corporate | 2013 | — |
| 0 (this device) | K162929 | Stryker Navigation System with CranialMap software application, Stryker… | Stryker Corporation | 2017 | — |
| +1 | K212194 | Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker… | Stryker Corporation | 2023 | 2 |
| +2 | K233542 | Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software… | Stryker Leibinger GmbH & Co KG | 2024 | — |
| +1 | K223288 | Cranial Navigation, Navigation Software Cranial, Navigation Software… | Brainlab AG | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 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.
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.
What descends from it? (3)
2 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 17 years and passes through 4 companies; a new generation was cleared every 6.8 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K212194 (Stryker Corporation, 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K131214.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Navigation System, with the CranialMap software application, 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 should…
Read the full statement (409 words)
The Stryker Navigation System, with the CranialMap software application, 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 should be operated only by trained personnel such as surgeons and clinic staff.
The system assists in the positioning of instruments for cranial procedures, including:
- Cranial biopsies
- Puncture of abscesses
- Craniotomies
- Craniectomies
- Resection of tumors and other lesions
- Removal of foreign objects
- Skull base procedures
- Transnasal neurosurgical procedures
- Transphenoidal pituitary surgery
- Shunt placement, including pediatric shunt placement
- Placement of electrodes for recording, stimulation and lesion generation
- Endoscopic Sinus Surgery (ESS)
- Intranasal procedures
- Ear implant procedures
- Craniofacial procedures
- Skull reconstruction procedures
- Orbital cavity reconstruction procedures
The user should consult Chapter "System Accuracy" of the safety information to assess if the accuracy of the system is suitable for their needs.
The Stryker CranialMap Planning software application, when used on a compliant computer, is intended as a planning software to enable open or percutaneous computer-assisted surgery.
The software application is indicated for any medical condition in which the use of computer-assisted planning may be appropriate.
The software application should be operated only by trained personnel such as surgeons and clinic staff.
This can include the following cranial procedures:
- Cranial biopsies
- Puncture of abscesses
- Craniotomies
- Craniectomies
- Resection of tumors and other lesions
- Removal of foreign objects
- Skull base procedures
- Transnasal neurosurgical procedures
- Transphenoidal pituitary surgery
- Shunt placement, including pediatric shunt placement
- Placement of electrodes for recording, stimulation and lesion generation
- Endoscopic Sinus Surgery (ESS)
- Intranasal procedures
- Ear implant procedures
- Craniofacial procedures
- Skull reconstruction procedures
- Orbital cavity reconstruction procedures
The Stryker CranialMask Tracker is intended to be used as an accessory to the Stryker Navigation System, with the CranialMap software application. It is placed onto the patient’s face on top of the skin.
- In combination with preoperative and intraoperative imaging devices, it enables 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 procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162929 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162929: Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162929
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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