FDA applicant

Depuy Orthopedics, Inc.

Warsaw, IN1 decision2024–20240 recalls

FDA records 1 decision for Depuy Orthopedics, Inc. (Warsaw, IN) in 2024: 1 510(k) clearance. All are in product code OIY (Prosthesis, Knee, Patellofemorotibial…). Its devices cite 2 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 Depuy Orthopedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

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

Planning a device like Depuy Orthopedics, 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 “Depuy”

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

Depuy, Inc. 307 DePuy Orthopaedics, Inc. 213 Depuy Spine, Inc. 73 Depuy Mitek, A Johnson & Johnson Company 59 Depuy Ireland UC 50 DePuy Synthes 20 Depuy Mitek 15 Depuy (Ireland) 13 Depuy Ace Medical Co. 10 Depuy Mitek, Inc., A Johnson and Johnson Company 6 Depuy Motech Acromed 4 Depuy France S.A.S. 4

Depuy Orthopedics, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Depuy”