510(k) Report

FDA applicant

Depuy Synthes Spine

Raynham, MA3 decisions2014–20191 recall

FDA records 3 decisions for Depuy Synthes Spine (Raynham, MA) from 2014 to 2019: 3 510(k) clearances. Most are in product codes MDI (Prosthesis, Rib Replacement) and MAX (Intervertebral Fusion Device With Bone Graft…). Its devices cite 5 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Depuy Synthes Spine, Inc.”.

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 Synthes Spine’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2014: 12018: 12019: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2015

2015: 1
2014high 1 (2015) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Depuy Synthes Spine by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MDIProsthesis, Rib Replacement1decision
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision
  • MQPSpinal Vertebral Body Replacement Device1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K142587Vertical Expandable Prosthetic Titanium RibDepuy Synthes Spine, Inc. · 20141cites it

What has FDA decided for it lately?

  • K183054SYNMESH SystemDepuy Synthes Spine · 2019
  • K181231DePuy Synthes T-PAL Spacer SystemDepuy Synthes Spine · 2018
  • K142587Vertical Expandable Prosthetic Titanium RibDepuy Synthes Spine, Inc. · 20141 recall

All 2 as Depuy Synthes Spine →The one decision as Depuy Synthes Spine, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K142587VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal…Jul 29, 2015Class II

Other applicant names beginning “Depuy”

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

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