OTS Hip

K250086

Ortoma AB · cleared 2025-05-16 · product code OLO · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“OTS Hip is comprised of software systems and hardware components that work together to form a stereotaxic system.”
Algorithmfixed/static machine learning (ML) algorithms for segmentation and landmark identification, including Sacral Slope landmark for x-ray images.
source quote (p.7)
“Both devices detect landmarks and perform segmentation using fixed/static machine learning (ML) algorithms and generate a 3D model based on the segmentation.”
Adaptive (vs locked)No
source quote (p.7)
“Both devices detect landmarks and perform segmentation using fixed/static machine learning (ML) algorithms and generate a 3D model based on the segmentation.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (6)

Bench

sample size not stated

endpoints: inclination; anteversion; mean deviation for position error; leg length inequality

Bench

sample size not stated

endpoints: conformance to IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION; conformance to IEC 60601-1-2:2014 [Including AMD 1:2021]

standards: IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION, IEC 60601-1-2:2014 [Including AMD 1:2021]

Retrospective clinical

n=90 cases

endpoints: accuracy of Machine Learning (ML) algorithms for segmentation and landmark identification

Retrospective clinical

n=276 patients

endpoints: accuracy of Machine Learning (ML) algorithms for Sacral Slope landmark added for x-ray images

Bench

sample size not stated

endpoints: accuracy performance of the localization and tracking technology

standards: ASTM Standard F2554-18

Bench

sample size not stated

standards: ISO 14971:2019 Medical devices – Application or Risk Management to medical devices

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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/K250086