FDA applicant

Innovate Orthopaedics Limited

Huddersfield, GB3 decisions2021–20250 recalls

FDA records 3 decisions for Innovate Orthopaedics Limited (Huddersfield, GB) from 2021 to 2025: 3 510(k) clearances. All are in product code HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 139 days from receipt to decision, against 104 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Innovate Orthopaedics, 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 Innovate Orthopaedics Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Innovate Orthopaedics Limited by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Innovate Orthopaedics Limited’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 “Innovate”

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

Innovate, Inc. 1

Innovate Orthopaedics Limited

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 “Innovate”