FDA applicant

Depuy France S.A.S.

Warsaw, IN4 decisions2012–20183 recalls

FDA records 4 decisions for Depuy France S.A.S. (Warsaw, IN) from 2012 to 2018: 4 510(k) clearances. Most are in product codes PHX (Shoulder Prosthesis, Reverse Configuration) and KWY (Prosthesis, Hip, Hemi-, Femoral…). Its devices cite 10 predicates, 1 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Depuy France”.

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 France S.A.S.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2012high 2 (2012) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2018

2012high 2 (2017) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Depuy France S.A.S. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Depuy France S.A.S.’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 Spine, A Johnson & Johnson Company 4

Depuy France S.A.S.

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?

What has been recalled?

Other applicant names beginning “Depuy”