Customize

K221432

3D-Side SA · cleared 2022-08-03 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“Customize for ankle arthroplasty is intended to be used as a software interface to assist in: Visualization, modification, validation of the planning of total ankle arthroplasty”
Algorithmartificial intelligence including nonadaptive machine learning
source quote (p.5)
“Both devices implement artificial intelligence including nonadaptive machine learning, followed by human supervision.”
Adaptive (vs locked)No
source quote (p.5)
“Both devices implement artificial intelligence including nonadaptive machine learning, followed by human supervision.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=126 images

endpoints: segmentation validation of the Customize software; Repeatability and Reproducibility (R&R) study on the segmentation of ankle anatomies; accuracy study on 3D model generation for tibia and talus

Reported performance (1 observation)

accuracyas written: “accuracy study on 3D model generation for tibia and talus”stated without value
source quote (p.6)
“3) accuracy study on 3D model generation for tibia and talus”

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/K221432