FDA applicant

Orthofix US, LLC

Lewisville, TX5 decisions2022–20250 recalls

FDA records 5 decisions for Orthofix US, LLC (Lewisville, TX) from 2022 to 2025: 4 510(k) clearances and 1 original PMA approval. Most are in product codes LLZ (System, Image Processing, Radiological) and MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 180 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 11 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 Orthofix US, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2022high 3 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Orthofix US, LLC by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Orthofix US, LLC’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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Other applicant names beginning “Orthofix”

FDA records each applicant name separately; these may or may not be the same firm.

Orthofix, Inc. 100 Orthofix Medical, Inc. 1

Orthofix US, LLC

Which product codes does it file in?

How long do its 510(k) reviews take?

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?

Other applicant names beginning “Orthofix”