FDA applicant

Bionx Implants, Inc.

Tampere, FI30 decisions1998–20030 recalls

FDA records 30 decisions for Bionx Implants, Inc. (Tampere, FI) from 1998 to 2003: 30 510(k) clearances. Most are in product codes MAI (Fastener, Fixation, Biodegradable, Soft Tissue) and HWC (Screw, Fixation, Bone). Its devices cite 118 predicates, 32 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Bionx Implants, Ltd.”.

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 Bionx Implants, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bionx Implants, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Bionx Implants, Inc.

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?