510(k) Report

FDA applicant

3D-Side S.A.

Mont-Saint-Guibert, BE4 decisions2021–20250 recalls

FDA records 4 decisions for 3D-Side S.A. (Mont-Saint-Guibert, BE) from 2021 to 2025: 4 510(k) clearances. Most are in product codes QIH (Automated Radiological Image Processing Software) and QHE (Shoulder Arthroplasty Implantation System). Since 2016 its 510(k)s took a median of 103 days from receipt to decision, against 134 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “3D-Side”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided 3D-Side S.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2021: 12022: 22025: 1
2021high 2 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — 3D-Side S.A. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QIHAutomated Radiological Image Processing Software2decisions
  • QHEShoulder Arthroplasty Implantation System1decision
  • PBFOrthopaedic Surgical Planning And Instrument Guides1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 103 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 134 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K2122373D-Cut3D-Side S.A. · 20211cites it
  • K213779Customize3D-Side S.A. · 20221cites it

What has FDA decided for it lately?

  • K243509Archer PSI System3D-Side · 2025
  • K221432Customize3D-Side S.A. · 2022
  • K213779Customize3D-Side S.A. · 2022
  • K2122373D-Cut3D-Side S.A. · 2021

All 3 as 3D-Side S.A. →The one decision as 3D-Side →