Stealth AXiS Cranial clinical application

K253379

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

Premarket evidence — what FDA accepted

Device typesimd

source quote (p.5)

“The Stealth AXIS™ Cranial clinical application works in conjunction with the Stealth AXIS™ Surgical System. The Stealth AXIS™ Cranial clinical application helps guide surgeons during cranial procedures such as biopsies, tumor resections, shunt placements and depth electrode and probe placement. The system tracks the position of instruments in relation to surgical anatomy and identifies this position on diagnostic or intraoperative images of the patient.”

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 AI 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; trajectory angle accuracy

Retrospective clinical

n=0 images

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

Reported performance (2 observations)

accuracyas written: “3D positional accuracy”2

source quote (p.7)

“Under representative worst-case configuration, the Stealth AXIS™ Surgical System with Stealth AXIS™ Cranial clinical application has demonstrated performance in 3D positional accuracy with a mean error ≤ 2.0 mm”

accuracyas written: “trajectory angle accuracy”2

source quote (p.7)

“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

recalls in product code, 24mo

1922

MAUDE reports in code, 12mo

-39%

vs code's own 3-yr baseline

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

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). 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).