510(k) Report

FDA applicant

Hyprevention Sas

Pessac Cedex, FR2 decisions2020–20240 recalls

FDA records 2 decisions for Hyprevention Sas (Pessac Cedex, FR) from 2020 to 2024: 2 510(k) clearances. All are in product code NDN (Cement, Bone, Vertebroplasty). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Hyprevention”.

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 Hyprevention Sas’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2020: 12024: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Hyprevention Sas by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hyprevention Sas’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?

  • NDNCement, Bone, Vertebroplasty2decisions

Whose devices does it build on?

Its devices cite 2 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.

  • K191709V-STRUT Vertebral ImplantHyprevention Sas · 20202cite it

What has FDA decided for it lately?

  • K240084V-STRUT® Vertebral ImplantHyprevention · 2024
  • K191709V-STRUT Vertebral ImplantHyprevention Sas · 2020

The one decision as Hyprevention Sas →The one decision as Hyprevention →