Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application

K253381

Medtronic Navigation, Inc. · cleared 2026-02-12 · product code OLO · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“The Stealth AXIS™ Surgical System is a computer-assisted surgery system that is composed of a platform, clinical application, surgical instruments, and a referencing system (which includes patient and instrument trackers). With the addition of the Stealth AXIS™ Autopilot to the Stealth AXIS™ Core, the Stealth AXIS™ Surgical System becomes a robotic-assisted surgery system.”
AlgorithmArtificial Intelligence (AI) to automate pedicle screw placement using a Siamese Neural Network and deep learning AI to automatically segment vertebrae using a locked UNet-based model.
source quote (p.12)
“The auto-planning feature in the Stealth AXIS Spine clinical application uses Artificial Intelligence (AI) to automate pedicle screw placement for spinal surgeries, providing patient-specific recommendations for select Medtronic screw types. This feature employs a Siamese Neural Network to compare candidate screw placements to expert standards, using inputs of deep learning-based spine segmentation and rule-based spinal features algorithms. The Automatic Spine Segmentation feature in the Stealth AXiS Spine clinical application uses deep learning AI to automatically segment vertebrae from CT and CBCT (O-arm) images, supporting planning and guidance for spine surgery. This locked UNet-based model distinguishes vertebrae in 3D images, with its vertebral segmentation dependent on image quality and then user verification. The network was trained and validated using internal and public datasets. employing patch-wise training and early stopping to prevent overfitting.”
Adaptive (vs locked)No
source quote (p.12)
“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

standards: AAMI ES60601-1:2005/AMD1:2012, AAMI ES60601;1:2005/AMD2:2021, IEC 60601-1-2:2014+ A1:2020

Retrospective clinical

sample size not stated

endpoints: screw placement similarity to expert; vertebrae segmentation accuracy

Reported performance (2 observations)

accuracyas written: “3D positional accuracy”2
source quote (p.11)
“Under representative worst-case configuration, the Stealth AXIS Surgical System with Stealth AXIS Spine 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.11)
“and in trajectory angle accuracy with a mean error of 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

25
recalls in product code, 24mo
2666
MAUDE reports in code, 12mo
+26%
vs code's own 3-yr baseline
4
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code OLO (Medtronic Navigation, Inc., initiated 2024-08-22): "Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, informat" Recalling firm matches this device's applicant.

    first seen 2026-07-08 · recall res_event_number:95283

  • recall_reason_pattern

    Software/algorithm-related recall in product code OLO (, initiated 2025-12-10): "Software errors that can result in incorrect surgical instrument positioning during spinal surgery." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98199

  • recall_reason_pattern

    Software/algorithm-related recall in product code OLO (Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France, initiated 2025-03-05): "Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance proh" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:96437

  • recall_reason_pattern

    Software/algorithm-related recall in product code OLO (, initiated 2024-07-17): "Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and t" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95189

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 2024-12-04

    Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.

    recall event 95970 (openFDA)

  • Recalling firm matches this device's applicant (Medtronic Navigation, Inc.) — same firm and product code, not necessarily this device · initiated 2024-08-22

    Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal.

    recall event 95283 (openFDA)

  • Recalling firm matches this device's applicant (Medtronic Navigation, Inc.) — same firm and product code, not necessarily this device · initiated 2023-11-28

    Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove.

    recall event 93611 (openFDA)

  • Recalling firm matches this device's applicant (Medtronic Navigation, Inc.) — same firm and product code, not necessarily this device · initiated 2023-11-28

    Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove.

    recall event 93611 (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/K253381