FDA applicant

Biomet Micofixation

Jacksonville, FL3 decisions2021–20220 recalls

FDA records 3 decisions for Biomet Micofixation (Jacksonville, FL) from 2021 to 2022: 3 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HBE (Drills, Burrs, Trephines & Accessories…). Its devices cite 3 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 Biomet Micofixation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2021high 2 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

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

Planning a device like Biomet Micofixation’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 “Biomet”

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

Biomet, Inc. 446 Biomet Manufacturing Corp 129 Biomet Orthopedics, Inc. 41 Biomet 3i, Inc. 32 Biomet Microfixation 31 Biomet Spine 23 Biomet Sports Medicine 13 Biomet Spine (Aka Ebi, LLC) 13 Biomet Trauma 7 Biomet Trauma (Aka Ebi, Lp) 4 Biomet UK, Ltd. 3 Biomet Manufactuting Corp. 2

Biomet Micofixation

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?

Other applicant names beginning “Biomet”