510(k) Report

FDA applicant

Stuckenbrock Medizintechnik GmbH

Tuttlingen, DE3 decisions2004–20180 recalls

FDA records 3 decisions for Stuckenbrock Medizintechnik GmbH (Tuttlingen, DE) from 2004 to 2018: 3 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and KXE (Prosthesis, Wrist, Hemi-, Ulnar). Its devices cite 6 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 Stuckenbrock Medizintechnik GmbH’s devices, and how often a recall has named them.

FDA decisions per year

2in 2018

2018: 2
2007high 2 (2018) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Stuckenbrock Medizintechnik GmbH by year, 2007–2026Sources: 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, Bone1decision
  • KXEProsthesis, Wrist, Hemi-, Ulnar1decision
  • HWCScrew, Fixation, Bone1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K171624IXOS Radius Plate SystemStuckenbrock Medizintechnik GmbH · 2018
  • K171628HBS2 Headless Bone ScrewStuckenbrock Medizintechnik GmbH · 2018
  • K042902Herbert Ulnar Head Prosthesis SystemStuckenbrock Medizintechnik GmbH · 2004

All 3 as Stuckenbrock Medizintechnik GmbH →