Customize

K213779

3D-Side SA · cleared 2022-03-16 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“Customize for shoulder arthroplasty is intended to be used as a software interface to assist in: Visualization, modification, validation of the planning of shoulder arthroplasty Communication of treatment options Segmentation of CT-scan data 3D CAD models generation Managing timeline and cases”

AlgorithmFDA source did not state this

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

endpoints: segmentation validation of the Customize software; Repeatability and Reproducibility study on the segmentation of shoulder anatomies; accuracy study on 3D model generation for humerus and scapula

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) K221432 (decision 2022-08-03) from 3D-Side SA for a matching device line ("Customize") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K221432

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).