510(k) Report

FDA applicant

S.M.A.I.O

Saint-Priest, FR13 decisions2020–20260 recalls

FDA records 13 decisions for S.M.A.I.O (Saint-Priest, FR) from 2020 to 2026: 13 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 96 days from receipt to decision, against 91 for FDA’s reviews in the same codes and years. Its devices cite 50 predicates, 29 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 S.M.A.I.O’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2020: 12021: 12022: 22023: 22025: 22026 (partial year): 5
2020high 5 (2026) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — S.M.A.I.O by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like S.M.A.I.O’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NKBThoracolumbosacral Pedicle Screw System10decisions
  • LLZSystem, Image Processing, Radiological3decisions

How long do its 510(k) reviews take?

Since 2016, its 13 510(k)s took a median of 96 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 91 days; 7 of its 13 were faster than that.

Whose devices does it build on?

Its devices cite 50 predicates; 29 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 30 times; 29 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.

  • K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O · 20227cite it
  • K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 20236cite it
  • K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 20254cite it
  • K201659KHEIRON® Spinal Fixation SystemS.M.A.I.O · 20203cite it
  • K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 20262cite it
  • K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 20252cite it

What has FDA decided for it lately?

  • K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
  • K261500KBA3D (v2.4.0)S.M.A.I.O · 2026
  • K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
  • K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
  • K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
  • K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025
  • K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025
  • K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2023

All 13 as S.M.A.I.O →