UNiD™ Spine Analyzer

K251629

Medicrea International S.A.S. (Medtronic) · cleared 2025-08-07 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“The UNID™ Spine Analyzer is a web-based application developed to perform preoperative and postoperative patient image measurements and simulate preoperative planning steps for spine surgery.”
AlgorithmAI-enabled device software functions (AI-DSF) which give indication to the user about compensatory mechanisms the patient could experience after the surgery according to the planned instrumentation. Depending on the type of surgery (Adult, Pediatric or Degenerative), a specific predictive model is available. The subject device incorporates a new version of the Degenerative Predictive model compared to the predicate device.
source quote (p.8)
“The software incorporates AI-DSF, which give indication to the user about compensatory mechanisms the patient could experience after the surgery according to the planned instrumentation. Depending on the type of surgery (Adult, Pediatric or Degenerative), a specific predictive model is available. The subject device incorporates a new version of the Degenerative Predictive model compared to the predicate device.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedYes
source quote (p.9)
“The cybersecurity testing was conducted on the UNID™ Spine Analyzer in accordance with ANSI AAMI SW96 and IEC 81001-5-1 to ensure the software integrity, confidentiality and availability. Activities performed as part of cybersecurity testing included: security risk assessment and threat modeling, vulnerability assessment, and penetration testing.”

Validation studies (1)

Retrospective clinical

n=1,050 patients

endpoints: Non-inferiority based on Mean Absolute Errors (MAEs)

standards: IEC 62304, IEC 82304-1, ANSI AAMI SW96, IEC 81001-5-1, IEC 62366-1

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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

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 Radiology 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/K251629