ARVIS® Shoulder

K240062

Insight Medical Systems, Inc. · cleared 2024-04-29 · product code OLO · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“ARVIS® Shoulder combines software, electronic hardware and surgical instruments to intraoperatively track tools and locate anatomical structures based on the patient's preoperative imaging. The preoperative planning platform uses AI-based automatic image segmentation and landmarking algorithms.”
AlgorithmAI-based automatic image segmentation and landmarking algorithms
source quote (p.6)
“The preoperative planning platform uses AI-based automatic image segmentation and landmarking algorithms.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=60 patients

endpoints: Dice Similarity Coefficient (DSC); Mean Absolute Distance (MAD); Hausdorff Distance (HD); Euclidean Distance (ED); Angular Separation (AS); Successful Point and Angular Classification Rates (SPCR, SACR)

Reported performance (2 observations)

diceas written: “Scapula Avg DSC”0.981
source quote (p.8)
“Scapula Avg DSC > 0.9 Result 0.981”
diceas written: “Humerus Avg DSC”0.989
source quote (p.8)
“Humerus Result 0.989”

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/K240062