Mazor X System / Mazor X Stealth Edition

K251316

Mazor Robotics Ltd. · cleared 2025-09-11 · product code OLO · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“The Mazor X system combines robotic trajectory guidance with navigated surgical instruments (either guided or free hand navigation) to enable the surgeon to precisely position surgical instruments and/or implants according to predefined planning. With the imaging capabilities of the system, the user can also visualize the implants on the patients CT. Same as the predicate device the modified Mazor X consists of a workstation with dedicated software, the surgical system, navigation camera, accessories, instruments and disposable kits. The modified Mazor X, the subject of this 510(k) application, introduces software and hardware modifications to the Mazor X System cleared in 510(k) K230064. The software incorporates the 2D Automatic Measurements feature which automatically detects key spinopelvic landmarks and produces spinopelvic measurements on AP and LAT X-rays images. The feature utilizes two locked AI algorithms: the Endplate detection algorithm and the Femoral head detection algorithm.”
Algorithmlocked machine learning based algorithm that automatically detects anatomical landmarks and calculates anatomical measurements, and a locked machine learning based algorithm that automatically suggests initial pedicle screw positions.
source quote (p.11)
“2D Automatic Measurements: incorporates a locked machine learning based algorithm that automatically detects anatomical landmarks, used for calculating anatomical measurements, for the automatic pre-op planning capability. The software incorporates the 2D Automatic Measurements feature which automatically detects key spinopelvic landmarks and produces spinopelvic measurements on AP and LAT X-rays images. The feature utilizes two locked AI algorithms: the Endplate detection algorithm and the Femoral head detection algorithm. The software incorporates the Plan Assist feature, which automatically suggests initial pedicle screw positions during spinal surgery planning using locked AI algorithm”
Adaptive (vs locked)No
source quote (p.11)
“2D Automatic Measurements: incorporates a locked machine learning based algorithm that automatically detects anatomical landmarks, used for calculating anatomical measurements, for the automatic pre-op planning capability. Plan Assist feature, a locked machine learning based algorithm, enhances the initial screw placement by considering user preferences and clinical constrains, thus providing clinically acceptable initial screw placement.”
PCCPNo
Cybersecurity addressedYes
source quote (p.14)
“Mazor X system is developed in accordance with the Cybersecurity design controls to ensure Mazor X Cybersecurity and maintain safety and effectiveness, similarly to the currently cleared device.”

Validation studies (2)

Retrospective clinical

n=399 images

endpoints: Single measurement absolute agreement intraclass correlation coefficient (ICC) was used to assess agreement the AI measurement results and the reference standard. The acceptance criterion of the ICC of least 0.75 with a 95% confidence level was achieved for all spinopelvic measurements.

Retrospective clinical

n=25 images

endpoints: The True Positive Rate (TPR) exceeded 80% with 95% confidence, meeting the acceptance criteria.

Reported performance (6 observations)

accuracyas written: “Mazor X System mean accuracy”1.5
source quote (p.13)
“Mazor X System mean accuracy <1.5mm”
accuracyas written: “Navigation Accuracy mean positional error”2
source quote (p.13)
“Navigation Accuracy mean positional error <2mm and mean trajectory error of 2°.”
accuracyas written: “Navigation Accuracy mean trajectory error”2
source quote (p.13)
“Navigation Accuracy mean positional error <2mm and mean trajectory error of 2°.”
accuracyas written: “Facet Decortication depth accuracy”1.5
source quote (p.13)
“Mazor X will also provide Facet Decortication depth accuracy within 1.5mm.”
agreement_kappaas written: “Intraclass Correlation Coefficient (ICC)”0.75CI 95% confidence level
source quote (p.18)
“Single measurement absolute agreement intraclass correlation coefficient (ICC) was used to assess agreement the AI measurement results and the reference standard. The acceptance criterion of the ICC of least 0.75 with a 95% confidence level was achieved for all spinopelvic measurements.”
sensitivityas written: “True Positive Rate (TPR)”80CI 95% confidence
source quote (p.19)
“The True Positive Rate (TPR) exceeded 80% with 95% confidence, meeting the acceptance criteria.”

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 (, 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 (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 is another firm in the same product code.

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

  • 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

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/K251316