FDA applicant

Depuy Synthes Companies of Johnson & Johnson

West Chester, PA1 decision2015–20151 recall

FDA records 1 decision for Depuy Synthes Companies of Johnson & Johnson (West Chester, PA) in 2015: 1 510(k) clearance. All are in product code HBW (Fastener, Plate, Cranioplasty). Its devices cite 4 predicates, 0 of them its own earlier devices. 1 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, neurology panel, where it files most

How often FDA has decided Depuy Synthes Companies of Johnson & Johnson’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2024

2015high 1 (2024) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Depuy Synthes Companies of Johnson & Johnson by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Depuy Synthes Companies of Johnson &…’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 Synthes Companies of Johnson & Johnson

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Depuy”