# FH Industrie

- Location (FDA's records): Quimper Finistere, FR
- FDA decisions: 9 (2020–2026): 9 510(k) clearances
- Product codes: PHX (6), LLZ (2), HSB (1)
- 510(k) review time since 2016: median 82 days, against 130 for FDA's reviews in the same codes and years (6 of 9 faster)
- Predicates its devices cite: 32 (5 its own); citations of its devices by later devices: 6 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Fournitures Hospitalieres Industrie: 14 (https://510kreport.com/company/fournitures-hospitalieres-industrie)
- Tornier, Inc.: 4 (https://510kreport.com/company/tornier)
- Biomet, Inc.: 2 (https://510kreport.com/company/biomet)
- Jointpoint, Inc.: 1 (https://510kreport.com/company/jointpoint)
- Exactech, Inc.: 1 (https://510kreport.com/company/exactech)
- Encore Medical L.P.: 1 (https://510kreport.com/company/encore-medical)
- Biomet Manufacturing Corp: 1 (https://510kreport.com/company/biomet-manufacturing)
- Depuy, Inc.: 1 (https://510kreport.com/company/depuy)

## Firms that cite its devices most
- Pixee Medical: 1 (https://510kreport.com/company/pixee-medical)

## Its most-cited devices
- K201928: e-Ortho Shoulder Software (2020), cited by 2
- K202024: ARROW Short Stem Humeral System (2021), cited by 2
- K253345: JARVIS Diaphyseal Stem Standard (2025), cited by 1
- K242253: JARVIS Glenoid Reverse Shoulder Prosthesis (2024), cited by 1

## Recent decisions
- K254003: JARVIS Metaphyseal Stem (Jan 9, 2026)
- K253345: JARVIS Diaphyseal Stem Standard (Oct 29, 2025)
- K252411: JARVIS Glenoid Reverse Shoulder Prosthesis (Aug 28, 2025)
- K242253: JARVIS Glenoid Reverse Shoulder Prosthesis (Nov 25, 2024)
- K232226: ARROW Off-Centred Humeral Insert (Aug 29, 2023)
- K220758: e-Ortho Shoulder Software v1.1 (Sep 30, 2022)
- K202024: ARROW Short Stem Humeral System (Nov 30, 2021)
- K200127: TELEGRAPH® EVOLUTION Humeral Nailing System (Oct 1, 2020)

Source page: https://510kreport.com/company/fh-industrie