xvision Spine system

Authorization

K251639 added a Gen 2 headset and minor tracking changes while retaining the same intended use and operating principle.

Submission lineageK251639 → predicate K250255.

Intended use

Aid precise localization of rigid spinal or pelvic anatomy relative to fluoroscopic or CT imagery during labeled open or percutaneous procedures.

Input

Registered fluoroscopic or CT anatomy; Wireless optical tracking data from surgical instruments and reference markers

Output

Two-dimensional stereotaxic views; Virtual instrument position relative to three-dimensional anatomy in a transparent near-eye display

Use boundary

The virtual display must not be relied on alone for absolute position and must be used with the stereotaxic display; the system does not choose a trajectory or perform the operation.

AI disclosure and function

AI function not established publicly

The summary describes minor enhancements to an optical tracking algorithm but does not identify a machine-learning architecture, training dataset or AI-derived clinical output.

FDA AI-list inclusion is confirmed at submission level, but the reviewed public summary is insufficient to characterize the listed AI function; no learning architecture is inferred.

No foundation-model, LLM, or generative-AI function was identified in the reviewed FDA materials.

Validation

Software, display, electrical, electromagnetic, positional-accuracy, phantom, cadaver and formative human-factors testing for the Gen 2 headset and minor tracking changes.

Comparator

The K250255 predicate configuration and prespecified system accuracy and display requirements.

Ground truth

Known phantom geometry and post-procedure cadaver imaging for positional, trajectory and Gertzbein-Robbins assessments.

Representation

Not applicable to the reported bench, phantom and cadaver testing; no patient cohort was described.

Reported performance

No numerical performance estimate was reported in the reviewed public summary for this submission.

Limitations

• The public summary does not report numerical accuracy results or a patient cohort.
• The cadaver and formative human-factors work does not establish complication reduction or superior clinical outcomes.
• The AI/ML architecture responsible for FDA list inclusion is not disclosed in the reviewed summary.

It does not publicly establish a particular AI architecture, superior screw placement, fewer complications or improved outcomes.

PCCP / Change control

No authorized PCCP was identified for this submission in the reviewed FDA database record or decision material.

Absence of an identified PCCP does not prevent every future device change; it means no authorized plan was established in the reviewed public record.

Postmarket check

FDA Class II recall Z-1761-2025 concerns 85 Perc Pin Adaptors used as a component of the xvision Spine system because of a tightening-knob usability issue and improperly placed tightening markings; the recall remained ongoing at review.

This is a component- and model-specific recall record, not evidence that every xvision Spine system or submission K251639 was recalled.

Primary FDA sources

1. FDA AI-enabled device list — Submission K251639Confirms inclusion, list display name, company, lead panel, product code and decision date only.
2. FDA submission database — 510(k) K251639Confirms pathway, Orthopedic review panel, decision and PCCP database field.
3. FDA decision summary — 510(k) summary pp. 1-4; performance pp. 3-4Supports intended use, predicate, device changes, nonclinical testing and AI-disclosure boundary.
4. FDA recall record — Recall Z-1761-2025Supports the specified Perc Pin Adaptor recall; it does not broaden the affected scope to every xvision system.

Sources checked Sep 8, 2026 · Next scheduled review Oct 8, 2026. “No exact-name result” is a bounded search finding, not proof that no safety event or recall exists.