FDA applicant

Avanti Orthopaedics, Inc.

Wilmington, DE4 decisions2019–20260 recalls

FDA records 4 decisions for Avanti Orthopaedics, Inc. (Wilmington, DE) from 2019 to 2026: 4 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 55 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Avanti Orthopaedics, LLC”.

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 Avanti Orthopaedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Avanti Orthopaedics, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Avanti Orthopaedics, Inc.’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

Other applicant names beginning “Avanti”

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

Avanti Polar Lipids, Inc. 1

Avanti Orthopaedics, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Avanti”