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FH Industrie: FDA-registered device maker in QUIMPER Finistere, France, 22 510(k) clearances

FH Industrie is registered with the FDA (registration 3003898228) in QUIMPER Finistere, France. It lists 11 device types. The FDA files 22 510(k) clearances under its listings, the newest dated January 9, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch FH Industrie
FDA registration number
3003898228
Address
Zi De Kernevez-6 Rue Nobel, QUIMPER Finistere, France, 29000
Owner or operator
FH ORTHOPEDICS INC (9025586)
Roles
Manufacturer
First device listed
December 8, 2010
Registered through
2026
Brand names listed
ARROW Anatomical Porous Glenoid, ARROW Humeral stems size 6 and 16, ARROW Off-Centred Humeral Insert, ARROW Short Stem Humeral System, ARROW anatomical shoulder system, ARROW reverse shoulder system, ARROW® Reverse Porous Glenoid, ARROW® Reverse Shoulder long keel and short keel glenoid base and more

Devices it lists

DeviceProduct codeClassRoleSource
Fastener, Fixation, Nondegradable, Soft TissueMBI2Manufactureraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Hemi-, Humeral, Metallic UncementedHSD2Manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer CementedKWT2Manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedKWS2Manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedMBF2Manufactureraccessdata.fda.gov
Rod, Fixation, Intramedullary And AccessoriesHSB2Manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Manufactureraccessdata.fda.gov
Shoulder Prosthesis, Reverse ConfigurationPHX2Manufactureraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 9, 2026K254003JARVIS Metaphyseal StemPHXSubstantially EquivalentFH Industrieaccessdata.fda.gov
October 29, 2025K253345JARVIS Diaphyseal Stem StandardPHXSubstantially EquivalentFH Industrieaccessdata.fda.gov
August 28, 2025K252411JARVIS Glenoid Reverse Shoulder ProsthesisPHXSubstantially EquivalentFH Industrieaccessdata.fda.gov
November 25, 2024K242253JARVIS Glenoid Reverse Shoulder ProsthesisPHXSubstantially EquivalentFH Industrieaccessdata.fda.gov
August 29, 2023K232226ARROW Off-Centred Humeral InsertPHXSubstantially EquivalentFH Industrieaccessdata.fda.gov
September 30, 2022K220758e-Ortho Shoulder Software v1.1LLZSubstantially EquivalentFH Industrieaccessdata.fda.gov
November 30, 2021K202024ARROW Short Stem Humeral SystemPHXSubstantially EquivalentFH Industrieaccessdata.fda.gov
October 1, 2020K200127TELEGRAPH® EVOLUTION Humeral Nailing SystemHSBSubstantially EquivalentFH Industrieaccessdata.fda.gov
September 30, 2020K201928e-Ortho Shoulder SoftwareLLZSubstantially EquivalentFH Industrieaccessdata.fda.gov
January 23, 2018K171789ARROW Reverse Porous GlenoidPHXSubstantially EquivalentFournitures Hospitalieres Industrieaccessdata.fda.gov
September 14, 2017K163148BePOD® Foot ScrewsHWCSubstantially EquivalentFournitures Hospitalieres Industrieaccessdata.fda.gov
September 8, 2017K163710BePOD® EZ Weil ScrewsHWCSubstantially EquivalentFournitures Hospitalieres Industrieaccessdata.fda.gov
April 10, 2017K162068ARROW Anatomical Porous glenoidMBFSubstantially EquivalentFournitures Hospitalieres Industrieaccessdata.fda.gov
April 4, 2017K170040BePOD Cannulated Arthrodesis ScrewsHWCSubstantially EquivalentFournitures Hospitalieres Industrieaccessdata.fda.gov
October 29, 2015K150568ARROW Humeral stems size 6 and 16PHXSubstantially EquivalentFournitures Hospitalieres Industrieaccessdata.fda.gov
May 22, 2015K150471CalcaNail Orthopedic Arthrodesis NailHSBSubstantially EquivalentFournitures Hospitalieres Industrieaccessdata.fda.gov
May 22, 2015K150463CalcaNail Orthopedic NailHSBSubstantially EquivalentFournitures Hospitalieres Industrieaccessdata.fda.gov
March 20, 2015K142778ARROW Reverse Shoulder long keel and short keel glenoid basePHXSubstantially EquivalentFournitures Hospitalieres Industrieaccessdata.fda.gov
March 5, 2013K120740COLS® FIXATION SYSTEMMBISubstantially EquivalentFournitures Hospitalieres Industrieaccessdata.fda.gov
July 12, 2012K112193ARROW REVERSE SHOULDER SYSTEMPHXSubstantially EquivalentFournitures Hospitalieres Industrieaccessdata.fda.gov
December 22, 2011K113591COLS PEEKHWCSubstantially EquivalentFournitures Hospitalieres Industrieaccessdata.fda.gov
November 24, 2010K093599ARROW ANATOMICAL SHOULDER SYSTEMKWSSubstantially EquivalentFournitures Hospitalieres Industrieaccessdata.fda.gov

Compare with other makers

Updated January 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.