510(k) Report

FDA applicant

Johnson and Johnson

Raynham, MA2 decisions2011–20141 recall

FDA records 2 decisions for Johnson and Johnson (Raynham, MA) from 2011 to 2014: 2 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and KWP (Appliance, Fixation, Spinal Interlaminal). 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, orthopedic panel, where it files most

How often FDA has decided Johnson and Johnson’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2011: 12014: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2015

2015: 1
2011high 1 (2015) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Johnson and Johnson by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Johnson and Johnson’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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Which product codes does it file in?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision
  • KWPAppliance, Fixation, Spinal Interlaminal1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 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.

  • K103488Concorde Bullet Cage SystemJohnson and Johnson · 20114cite it

What has FDA decided for it lately?

  • K142460EXPEDIUM Spine System/Synapse SystemJohnson and Johnson · 20141 recall
  • K103488Concorde Bullet Cage SystemJohnson and Johnson · 2011

All 2 as Johnson and Johnson →

What has been recalled?

1 recall linked to its devices; the latest:

  • K101070EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm…Apr 21, 2015Class II

Other applicant names beginning “Johnson”

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

Johnson & Johnson Professionals, Inc. 206Johnson & Johnson Medical, Inc. 56Johnson & Johnson Clinical Diagnostics, Inc. 33Johnson & Johnson Orthopaedics, Inc. 22Johnson & Johnson Vision Care, Inc. 13Johnson & Johnson 12Johnson & Johnson Surgical Vision, Inc. 11Johnson & Johnson International 10Johnson & Johnson Consumer Products, Inc. 8Johnson & Johnson Medical, Div. of Ethicon, Inc. 5Johnson & Johnson Patient Care, Inc. 4Johnson & Johnson Consumer Companies, Inc. 2