FDA applicant

Depuy Ace

Warsaw, IN2 decisions2004–20040 recalls

FDA records 2 decisions for Depuy Ace (Warsaw, IN) in 2004: 2 510(k) clearances. All are in product code HSB (Rod, Fixation, Intramedullary And Accessories). Its devices cite 4 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 Ace’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Depuy Ace since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Depuy Ace by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Depuy Ace’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 “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 Ace

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 “Depuy”