Preview Shoulder
K240172Genesis Software Innovations · cleared 2024-04-04 · product code QIH · Radiology
Premarket evidence — what FDA accepted
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.”
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.”
source quote (p.4)
“Preview Shoulder is a secure software application used by qualified or trained surgeons and is accessed by authorized users.”
Validation studies (2)
Standalone
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
Bench
sample size not stated
endpoints: measurement capabilities of the Preview Shoulder were validated to be significantly equivalent to a benchmark tool with CT rendering measurement capabilities, Osirix MD (K101342)
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
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).