FDA applicant

Zimmer Biomet

Warsaw, IN6 decisions2024–20260 recalls

FDA records 6 decisions for Zimmer Biomet (Warsaw, IN) from 2024 to 2026: 6 510(k) clearances. Most are in product codes HSX (Prosthesis, Knee, Femorotibial…) and LZO (Prosthesis, Hip, Semi-Constrained…). Since 2016 its 510(k)s took a median of 60 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 9 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 Zimmer Biomet’s devices, and how often a recall has named them.

FDA decisions per year

4in 2025

2024high 4 (2025) · low 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Zimmer Biomet by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Zimmer Biomet’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 “Zimmer”

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

Zimmer, Inc. 426 Zimmer Spine, Inc. 44 Zimmer Dental, Inc. 40 Zimmer Biomet Spine, Inc. 15 Zimmer Medizinsysteme GmbH 13 Zimmer Trabecular Metal Technology 13 Zimmer Elektromedizin GmbH 12 Zimmer Trabecular 10 Zimmer Switzerland Manufacturing GmbH 4 Zimmer Patient Care Division 3 Zimmer Cas 3 Zimmer Medizinsystems GmbH 2

Zimmer Biomet

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 “Zimmer”