FDA applicant

Bioretec, Ltd.

Tampere, FI10 decisions2006–20260 recalls

FDA records 10 decisions for Bioretec, Ltd. (Tampere, FI) from 2006 to 2026: 9 510(k) clearances and 1 De Novo grant. Most are in product codes HTY (Pin, Fixation, Smooth) and HWC (Screw, Fixation, Bone). Its devices cite 22 predicates, 10 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 Bioretec, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007high 2 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bioretec, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Bioretec, Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?