xvision Spine system

K250255

Augmedics Ltd. · cleared 2025-03-13 · product code SBF · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“The xvision Spine (XVS) system is an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery. The system consists of dedicated software, Headset, single use passive reflective markers and reusable components.”
AlgorithmDeep-Learning Based Spine Segmentation Algorithms
source quote (p.10)
“Deep-Learning Based Spine Segmentation Algorithms”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.6)
“Software modifications include cybersecurity and HIPPA enhancement, adding GUI guidance and enforce allowable distances and angles for markers during registration.”

Validation studies (1)

Bench

sample size not stated

endpoints: mechanical stability; overall system accuracy; positional and angular accuracy during 2D/3D registration

standards: ISO 14971

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

1
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
2
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K251639 (decision 2025-10-03) from Augmedics, Ltd. for a matching device line ("xvision Spine system") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K251639

  • recall_reason_pattern

    Software/algorithm-related recall in product code SBF (Kico Knee Innovation Company, initiated 2025-09-19): "Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97618

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/K250255