510(k) Report

FDA applicant

Depuyacromed

Raynham, MA48 decisions1999–200415 recalls

FDA records 48 decisions for Depuyacromed (Raynham, MA) from 1999 to 2004: 48 510(k) clearances. Most are in product codes MNH (Orthosis, Spondylolisthesis Spinal Fixation) and KWP (Appliance, Fixation, Spinal Interlaminal). Its devices cite 88 predicates, 47 of them its own earlier devices. 15 recalls are 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 Depuyacromed’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Depuyacromed since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • MNHOrthosis, Spondylolisthesis Spinal Fixation13decisions
  • KWPAppliance, Fixation, Spinal Interlaminal10decisions
  • MQPSpinal Vertebral Body Replacement Device8decisions
  • MNIOrthosis, Spinal Pedicle Fixation6decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body4decisions
  • LYCBone Grafting Material, Synthetic2decisions

Also: FMF (1), JEC (1), GEY (1), MRW (1), MQV (1).

Whose devices does it build on?

Its devices cite 88 predicates; 47 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 333 times; 47 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.

  • K0226235.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Depuyacromed · 200229cite it
  • K003043Surgical Titanium Mesh SystemDepuyacromed · 200126cite it
  • K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 200323cite it
  • K992168Moss Miami 6.35MM Polyaxial ScrewDepuyacromed · 199922cite it
  • K001340Stackable Cage SystemDepuyacromed · 200017cite it
  • K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 200016cite it

What has FDA decided for it lately?

  • K040197Eagle Anterior Cervial Plate SystemDepuyacromed · 2004
  • K031635Depuy Acromed VBR SystemDepuyacromed · 2003
  • K030833Depuy Acromed VBR SystemDepuyacromed · 2003
  • K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
  • K030249Surgical Titanium Mesh SystemDepuyacromed · 2003
  • K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  • K023835Devex Mesh SystemDepuyacromed · 2003
  • K024348Monarch Spine SystemDepuyacromed · 2003

All 48 as Depuyacromed →

What has been recalled?

15 recalls linked to its devices; the latest:

  • K915800DePuy Spine Bremer 3-D Halo Crown System Product Code: 2923-01-100Oct 10, 2006
  • K915800Small Pediatric Ring, DePuy Spine Bremer Halo System Product Code: PT001Oct 10, 2006
  • K915800HI Fix Skull Pins, DePuy Spine Bremer Halo System Product Code: AC020Oct 10, 2006
  • K915800Small Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System Product Code: HT025HIOct 10, 2006
  • K915800Adjustable Ring Traction Set, Size B, DePuy Spine Bremer Halo System Product Code: HT001Oct 10, 2006
  • K915800Large Pediatric Ring, DePuy Spine Bremer Halo System Product Code: PT002Oct 10, 2006