Preview Shoulder

K240172

Genesis Software Innovations · cleared 2024-04-04 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“The Preview Shoulder, a 3D total shoulder arthroplasty (TSA) surgical planning software, is a standalone software application which assists the surgeon in planning reverse and anatomic shoulder arthroplasty.”
AlgorithmPost-processing algorithm is added to further refine the 3D mesh quality. Algorithm is added to calculate humerus-side features used for implant selection, placement, and pre-surgical planning.
source quote (p.7)
“Post-processing algorithm is added to further refine the 3D mesh quality. Algorithm is added to calculate humerus-side features used for implant selection, placement, and pre-surgical planning.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

endpoints: assess the safety and effectiveness of the device; demonstrate the processing of patient images to produce accurate and repeatable 3D reconstructed bones and surgical coordinates provided to the surgeon; measurement capabilities validated to be significantly equivalent to a benchmark tool with CT rendering measurement capabilities

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/K240172