510(k) Report

FDA applicant

Wittenstein Intens GmbH

Igersheim, DE2 decisions2017–20210 recalls

FDA records 2 decisions for Wittenstein Intens GmbH (Igersheim, DE) from 2017 to 2021: 2 510(k) clearances. All are in product code HSB (Rod, Fixation, Intramedullary And Accessories). Its devices cite 5 predicates, 1 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 Wittenstein Intens GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2017: 12021: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Wittenstein Intens GmbH by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • HSBRod, Fixation, Intramedullary And Accessories2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K203399Fitbone (R) TaaWittenstein Intens GmbH · 20214cite it
  • K163368Fitbone TaaWittenstein Intens GmbH · 20171cites it

What has FDA decided for it lately?

  • K203399Fitbone (R) TaaWittenstein Intens GmbH · 2021
  • K163368Fitbone TaaWittenstein Intens GmbH · 2017

All 2 as Wittenstein Intens GmbH →