510(k) Report

FDA applicant

FH Industrie

Quimper Finistere, FR9 decisions2020–20260 recalls

FDA records 9 decisions for FH Industrie (Quimper Finistere, FR) from 2020 to 2026: 9 510(k) clearances. Most are in product codes PHX (Shoulder Prosthesis, Reverse Configuration) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 82 days from receipt to decision, against 130 for FDA’s reviews in the same codes and years. Its devices cite 32 predicates, 5 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 FH Industrie’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2020: 22021: 12022: 12023: 12024: 12025: 22026 (partial year): 1
2020high 2 (2020) · low 1 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — FH Industrie by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like FH Industrie’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

Which product codes does it file in?

  • PHXShoulder Prosthesis, Reverse Configuration6decisions
  • LLZSystem, Image Processing, Radiological2decisions
  • HSBRod, Fixation, Intramedullary And Accessories1decision

How long do its 510(k) reviews take?

Since 2016, its 9 510(k)s took a median of 82 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 130 days; 6 of its 9 were faster than that.

Whose devices does it build on?

Its devices cite 32 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 5 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.

  • K201928e-Ortho Shoulder SoftwareFH Industrie · 20202cite it
  • K202024ARROW Short Stem Humeral SystemFH Industrie · 20212cite it
  • K253345JARVIS Diaphyseal Stem StandardFH Industrie · 20251cites it
  • K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie · 20241cites it

What has FDA decided for it lately?

  • K254003JARVIS Metaphyseal StemFH Industrie · 2026
  • K253345JARVIS Diaphyseal Stem StandardFH Industrie · 2025
  • K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie · 2025
  • K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie · 2024
  • K232226ARROW Off-Centred Humeral InsertFH Industrie · 2023
  • K220758e-Ortho Shoulder Software v1.1FH Industrie · 2022
  • K202024ARROW Short Stem Humeral SystemFH Industrie · 2021
  • K200127TELEGRAPH® EVOLUTION Humeral Nailing SystemFH Industrie · 2020

All 9 as FH Industrie →