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-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.

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.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

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 (5)

Retrospective clinical

n=1,050 cases

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

Bench

sample size not stated

endpoints: software is developed correctly and adheres to its design specifications

standards: IEC 62304

Bench

sample size not stated

endpoints: software satisfies the specified requirements and meets the user's needs

standards: IEC 82304-1

Bench

sample size not stated

endpoints: ensure the software integrity, confidentiality and availability

standards: ANSI AAMI SW96, IEC 81001-5-1

Bench

sample size not stated

endpoints: assess the software ergonomics and ensure no usability issues could raise significant risks in terms of safety and effectiveness

standards: 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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). 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).