510(k) Report

FDA applicant

Fournitures Hospitalieres Industrie

Quimper Finistere, FR24 decisions2002–20180 recalls

FDA records 24 decisions for Fournitures Hospitalieres Industrie (Quimper Finistere, FR) from 2002 to 2018: 24 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and HSB (Rod, Fixation, Intramedullary And Accessories). Since 2016 its 510(k)s took a median of 237 days from receipt to decision, against 127 for FDA’s reviews in the same codes and years. Its devices cite 64 predicates, 22 of them its own earlier devices. No 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 Fournitures Hospitalieres Industrie’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2007: 12008: 12010: 12011: 12012: 12013: 12015: 42017: 42018: 1
2007high 4 (2015) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Fournitures Hospitalieres Industrie 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?

  • HWCScrew, Fixation, Bone8decisions
  • HSBRod, Fixation, Intramedullary And Accessories6decisions
  • PHXShoulder Prosthesis, Reverse Configuration4decisions
  • LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous…2decisions
  • KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1decision
  • MBIFastener, Fixation, Nondegradable, Soft Tissue1decision

Also: MBF (1), GAT (1).

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 237 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 127 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 64 predicates; 22 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 40 times; 22 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.

  • K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie · 20128cite it
  • K093599Arrow Anatomical Shoulder SystemFournitures Hospitalieres Industrie · 20105cite it
  • K070617Cannulated ScrewFournitures Hospitalieres Industrie · 20074cite it
  • K042332Titanium Telegraph Humeral NailFournitures Hospitalieres Industrie · 20043cite it
  • K041456Snap-Off ScrewsFournitures Hospitalieres Industrie · 20043cite it
  • K033510Modification to Telegraph Humeral NailFournitures Hospitalieres Industrie · 20033cite it

What has FDA decided for it lately?

  • K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie · 2018
  • K163148BePOD® Foot ScrewsFournitures Hospitalieres Industrie · 2017
  • K163710BePOD® EZ Weil ScrewsFournitures Hospitalieres Industrie · 2017
  • K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie · 2017
  • K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie · 2017
  • K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie · 2015
  • K150471CalcaNail Orthopedic Arthrodesis NailFournitures Hospitalieres Industrie · 2015
  • K150463CalcaNail Orthopedic NailFournitures Hospitalieres Industrie · 2015

All 24 as Fournitures Hospitalieres Industrie →

Other applicant names beginning “Fournitures”

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

Fournitures Hospitalieres 4