510(k) Report

FDA applicant

Intrauma S.P.A

Rivoli (To), IT3 decisions2021–20250 recalls

FDA records 3 decisions for Intrauma S.P.A (Rivoli (To), IT) from 2021 to 2025: 3 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HSB (Rod, Fixation, Intramedullary And Accessories). Since 2016 its 510(k)s took a median of 179 days from receipt to decision, against 94 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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 Intrauma S.P.A’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2021: 12023: 12025: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Intrauma S.P.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?

  • HRSPlate, Fixation, Bone2decisions
  • HSBRod, Fixation, Intramedullary And Accessories1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 179 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 94 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K252959WRISTAR MultiAx Distal Radius KitIntrauma S.P.A · 2025
  • K230623KITE Distal Fibula KitIntrauma S.P.A · 2023
  • K201147Elos® Intramedullary Nailing SystemIntrauma S.P.A · 2021

All 3 as Intrauma S.P.A →