Preview Shoulder

K210556

Genesis Software Innovations · cleared 2021-04-21 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“The Preview Shoulder software is intended to be used as a tool for orthopedic surgeons to develop pre-operative shoulder plans based on a patient CT imaging study. 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. Preview Shoulder utilizes an AI algorithm for reconstructing 3D bone model from the image data.”

AlgorithmAI algorithm for reconstructing 3D bone model from the image data; nonadaptive machine learning algorithms

source quote (p.6)

“The QIH device definition applies to picture archiving and communications systems that implement artificial intelligence (AI) including nonadaptive machine learning algorithms. Preview Shoulder utilizes an AI algorithm for reconstructing 3D bone model from the image data.”

Adaptive (vs locked)No

source quote (p.6)

“The QIH device definition applies to picture archiving and communications systems that implement artificial intelligence (AI) including nonadaptive machine learning algorithms.”

PCCPFDA source did not state this

Cybersecurity addressedNo

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

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

re_clearance
The FDA AI/ML device list shows a newer 510(k) K240172 (decision 2024-04-04) from Genesis Software Innovations for a matching device line ("Preview Shoulder") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K240172

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).