Stealth AXiS Cranial clinical application

K253379

Medtronic Navigation, Inc. · cleared 2026-03-26 · product code HAW · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The Stealth AXIS™ Cranial clinical application works in conjunction with the Stealth AXIS™ Surgical System. The Automatic Tracts (Autotracts) feature in the Stealth AXIS Cranial clinical application uses Al and machine learning to automatically generate patient-specific white matter tracts from diffusion MRI images, streamlining pre-surgical planning.”
AlgorithmU-Net-based convolutional neural network for brain segmentation, constrained spherical deconvolution for tractography, and a random forest classifier to filter tracts.
source quote (p.10)
“Autotracts utilizes a locked U-Net-based convolutional neural network for brain segmentation, constrained spherical deconvolution for tractography, and a random forest classifier to filter tracts.”
Adaptive (vs locked)No
source quote (p.10)
“The Al model is locked and does not update after deployment.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

endpoints: 3D positional accuracy with a mean error ≤ 2.0 mm; trajectory angle accuracy with a mean error ≤ 2.0 degrees

Standalone

n=100 images

endpoints: Performance was assessed leveraging expert review to ensure reliability.

Reported performance (2 observations)

accuracyas written: “3D positional accuracy”2
source quote (p.9)
“Under representative worst-case configuration, the Stealth AXIS™ Surgical System with Stealth AXIS™ cranial application, has demonstrated performance in 3D positional accuracy with a mean error ≤ 2.0 mm and in trajectory angle accuracy with a mean error ≤ 2.0 degrees.”
accuracyas written: “trajectory angle accuracy”2
source quote (p.9)
“Under representative worst-case configuration, the Stealth AXIS™ Surgical System with Stealth AXIS™ cranial application, has demonstrated performance in 3D positional accuracy with a mean error ≤ 2.0 mm and in trajectory angle accuracy with a mean error ≤ 2.0 degrees.”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

5
recalls in product code, 24mo
1922
MAUDE reports in code, 12mo
-39%
vs code's own 3-yr baseline
1
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code HAW (Howmedica Osteonics Corp., initiated 2025-11-12): "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 in" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97988

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Medtronic Navigation, Inc.) — same firm and product code, not necessarily this device · initiated 2024-03-26

    Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.

    recall event 94411 (openFDA)

  • Recalling firm matches this device's applicant (Medtronic Navigation, Inc.) — same firm and product code, not necessarily this device · initiated 2023-09-27

    Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.

    recall event 93158 (openFDA)

  • Recalling firm matches this device's applicant (Medtronic Navigation, Inc.) — same firm and product code, not necessarily this device · initiated 2023-04-11

    During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other navigational information showing inaccurate values, which may result in prolonged/additional procedure, tissue injury

    recall event 92141 (openFDA)

  • Recalling firm matches this device's applicant (Medtronic Navigation, Inc.) — same firm and product code, not necessarily this device · initiated 2023-04-11

    In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain stimulation, where distance to/past target text no longer synchronized with navigation information, inaccurate value displayed; may result in prolonged/additional procedure, tissue injury

    recall event 92269 (openFDA)

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Neurology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K253379