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Data / Medical devices / France / Tornier S.A.S.

Tornier S.A.S.: FDA-registered device maker in Montbonnot Saint-Martin Isere, France, 43 510(k) clearances

Tornier S.A.S. is registered with the FDA (registration 3000931034) in Montbonnot Saint-Martin Isere, France. It lists 45 device types. The FDA files 43 510(k) clearances under its listings, the newest dated April 3, 2026. 5 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Tornier S.A.S.
FDA registration number
3000931034
Address
161 rue Lavoisier, Montbonnot Saint-Martin Isere, France, 38330
Owner or operator
STRYKER CORP. (1811755)
Roles
Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
First device listed
January 12, 1978
Registered through
2027
Brand names listed
10.5MM FLEXIBLE REAMER, 10MM FLEXIBLE REAMER, 10mm SUBFIX TRIAL, 11.5MM FLEXIBLE REAMER, 11.5mm SUBFIX TRIAL, 11MM FLEXIBLE REAMER, 12MM FLEXIBLE REAMER, 135 mm Reusable Slat, SE Retr, 10 Pack and more

Devices it lists

DeviceProduct codeClassRoleSource
AwlHWJ1Complaint file establishment, Manufactureraccessdata.fda.gov
Bit, DrillHTW1Complaint file establishment, Manufactureraccessdata.fda.gov
Bit, SurgicalGFG1Complaint file establishment, Manufactureraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Complaint file establishment, Manufactureraccessdata.fda.gov
BroachHTQ1Contract manufactureraccessdata.fda.gov
Cement ObturatorLZN2Complaint file establishment, Manufactureraccessdata.fda.gov
ClampHXD1Complaint file establishment, Manufactureraccessdata.fda.gov
CuretteHTF1Complaint file establishment, Specification developeraccessdata.fda.gov
ElevatorHTE1Complaint file establishment, Manufactureraccessdata.fda.gov
ExtractorHWB1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
ForcepsHTD1Complaint file establishment, Manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Hammer, SurgicalFZY1Complaint file establishment, Specification developeraccessdata.fda.gov
ImpactorHWA1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Instrument, CompressionHWN1Complaint file establishment, Manufactureraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Manufactureraccessdata.fda.gov
Mesh, SurgicalFTM2Manufactureraccessdata.fda.gov
Mixer, Cement, For Clinical UseJDZ1Complaint file establishment, Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Complaint file establishment, Manufactureraccessdata.fda.gov
PasserHWQ1Contract manufactureraccessdata.fda.gov
Prosthesis, Elbow, Constrained, CementedJDC2Contract manufactureraccessdata.fda.gov
Prosthesis, Elbow, Hemi-, Radial, PolymerKWI2Complaint file establishment, Manufactureraccessdata.fda.gov
Prosthesis, Elbow, Semi-Constrained, CementedJDB2Complaint file establishment, Contract manufacturer, Manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedJDI2Complaint file establishment, Manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Hemi-, Humeral, Metallic UncementedHSD2Complaint file establishment, Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer CementedKWT2Complaint file establishment, Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, CementedPAO2Contract manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedKWS2Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-ConstrainedPKC2Contract manufacturer, Manufactureraccessdata.fda.gov
Prosthesis, Wrist, Carpal TrapeziumKYI2Exporter to the US, Manufactureraccessdata.fda.gov
Punch, SurgicalLRY1Complaint file establishment, Manufactureraccessdata.fda.gov
Pusher, SocketHXO1Complaint file establishment, Manufactureraccessdata.fda.gov
RaspHTR1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
ReamerHTO1Complaint file establishment, Manufactureraccessdata.fda.gov
RetractorGAD1Complaint file establishment, Manufactureraccessdata.fda.gov
Saw, Manual And AccessoriesGDR1Complaint file establishment, Specification developeraccessdata.fda.gov
ScrewdriverHXX1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Shoulder Arthroplasty Implantation SystemQHE2Complaint file establishment, Manufactureraccessdata.fda.gov
Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented ProsthesisQKW2Complaint file establishment, Manufactureraccessdata.fda.gov
Shoulder Prosthesis, Reverse ConfigurationPHX2Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Tap, BoneHWX1Manufactureraccessdata.fda.gov
TemplateHWT1Complaint file establishment, Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Complaint file establishment, Manufactureraccessdata.fda.gov
WrenchHXC1Complaint file establishment, Manufactureraccessdata.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
April 3, 2026K253674Blueprint Patient-Specific InstrumentationPHXSubstantially EquivalentStryker Corporation (Tornier, S.A.S.)accessdata.fda.gov
January 8, 2026K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)PHXSubstantially EquivalentTornier, Inc.accessdata.fda.gov
October 10, 2024K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidPHXSubstantially EquivalentStryker Corporation (Tornier, S.A.S.)accessdata.fda.gov
February 21, 2024K232265BLUEPRINT™ Patient Specific InstrumentationPHXSubstantially EquivalentTornier S.A.S.accessdata.fda.gov
December 16, 2022DEN220012Tornier Pyrocarbon Humeral HeadQKWUnknownTornier S.A.S.accessdata.fda.gov
November 12, 2021K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific InstrumentationPHXSubstantially EquivalentTornier, Inc.accessdata.fda.gov
June 12, 2019K190521Aequalis Ascend Flex Shoulder SystemKWSSubstantially EquivalentTornier S.A.S.accessdata.fda.gov
February 22, 2017K162800BLUEPRINT Patient Specific InstrumentationKWSSubstantially EquivalentTornier S.A.S.accessdata.fda.gov
December 27, 2016K161789BLUEPRINT Patient Specific InstrumentationKWSSubstantially EquivalentTornier S.A.S.accessdata.fda.gov
November 15, 2016K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidPHXSubstantially EquivalentTornier, Inc.accessdata.fda.gov
June 10, 2016K160555BLUEPRINT Patient Specific InstrumentationKWSSubstantially EquivalentTornier S.A.S.accessdata.fda.gov
September 24, 2015K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisKWSSubstantially EquivalentTornier S.A.S.accessdata.fda.gov
April 8, 2015K143374BLUEPRINT Patient Specific InstrumentationKWSSubstantially EquivalentTornier S.A.S.accessdata.fda.gov
March 4, 2015K143552Simpliciti Shoulder SystemPKCSubstantially EquivalentTornier, Inc.accessdata.fda.gov
August 6, 2014K140478AEQUALIS REVERSED SHOULDER PROSTHESISPHXSubstantially EquivalentTornier S.A.S.accessdata.fda.gov
July 18, 2014K140082AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEMPHXSubstantially EquivalentTornier S.A.S.accessdata.fda.gov
December 5, 2013K132285AEQUALIS REVERSED SHOULDER PROSTHESISPHXSubstantially EquivalentTornier S.A.S.accessdata.fda.gov
October 16, 2013K131231AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESISPHXSubstantially EquivalentTornier S.A.S.accessdata.fda.gov
January 8, 2013K122698AEQUALIS ASCEND FLEX SHOULDER SYSTEMKWSSubstantially EquivalentTornier S.A.S.accessdata.fda.gov
March 13, 2012K112144AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESISPHXSubstantially EquivalentTornieraccessdata.fda.gov
November 3, 2011K111902AEQUALIS SHOULDER SYSTEMKWSSubstantially EquivalentTornieraccessdata.fda.gov
May 6, 2010K100142AEQUALIS REVERSED SHOULDER PROSTHESISPHXSubstantially EquivalentTornieraccessdata.fda.gov
October 24, 2008K082120AEQUALIS REVERSED FRACTURE SHOULDER PROTHESISKWSSubstantially EquivalentTornieraccessdata.fda.gov
July 17, 2008K081059AEQUALIS REVERSED SHOULDER PROSTHESISPHXSubstantially EquivalentTornieraccessdata.fda.gov
October 18, 2007K071948AEQUALIS REVERSED ADAPTERPHXSubstantially EquivalentTornieraccessdata.fda.gov
September 14, 2006K061824TORNIER CEMENT RESTRICTORLZNSubstantially EquivalentTornieraccessdata.fda.gov
July 20, 2006K061439AEQUALIS REVERSED PROSTHESISPHXSubstantially EquivalentTornieraccessdata.fda.gov
May 10, 2006K060386NEXA CARPO METACARPAL IMPLANTKYISubstantially EquivalentNexa Orthopedics, Inc.accessdata.fda.gov
April 18, 2006K060438RHSJDBSubstantially EquivalentTornieraccessdata.fda.gov
March 2, 2006K060209AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEMKWSSubstantially EquivalentTornieraccessdata.fda.gov
March 16, 2005K050316AEQUALIS REVERSED SHOULDER PROSTHESISPHXSubstantially EquivalentTornieraccessdata.fda.gov
August 25, 2004K041873AEQUALIS REVERSED SHOULDER PROSTHESISPHXSubstantially EquivalentTornieraccessdata.fda.gov
June 17, 2004K041339AEQUALIS SHOULDER SYSTEMKWSSubstantially EquivalentTornieraccessdata.fda.gov
May 14, 2004K030941AEQUALIS REVERSED SHOULDER PROSTHESISPHXSubstantially EquivalentTornieraccessdata.fda.gov
August 15, 2001K012212MODIFICATION TO AEQUALIS SHOULDER SYSTEMKWSSubstantially EquivalentTornieraccessdata.fda.gov
July 13, 2001K011942AEQUALIS PRESS-FIT SHOULDER PROSTHESISHSDSubstantially EquivalentTornieraccessdata.fda.gov
August 31, 2000K994041TORNIER BIPOLAR RADIAL HEAD PROSTHESISKWISubstantially EquivalentTornier, Inc.accessdata.fda.gov
July 20, 2000K001932TORNIER CEMENT RESTRICTORJDISubstantially EquivalentTornieraccessdata.fda.gov
June 22, 2000K994393AEQUALIS UNIVERSAL SHOULDER GLENOIDKWSSubstantially EquivalentTornieraccessdata.fda.gov
March 10, 2000K994392AEQUALIS SHOULDER FRACTURE SYSTEMKWSSubstantially EquivalentTornieraccessdata.fda.gov
August 23, 1999K980244AEQUALIS SHOULDER PROSTHESISKWSSubstantially EquivalentTornieraccessdata.fda.gov
December 9, 1997K973453TORNIER CEMENT RESTRICTORJDISubstantially EquivalentTornieraccessdata.fda.gov
September 27, 1995K952928AEQUALIS SHOULDER SYSTEM FOR TOTAL & HEMISHOULDER APPLICATIONSKWSSubstantially EquivalentTornieraccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
April 10, 202596651Class IIOngoingBlueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.accessdata.fda.gov
March 5, 202596437Class IIOngoingstryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder ArthroplastyStryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and generaccessdata.fda.gov
December 18, 202496030Class IIOngoingStryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can result in the Blueprint Mixed Reality headset being unable to detect the Pin Guide and potentially prolonging surgery time or changing of surgical method from guided to conventional.accessdata.fda.gov
April 16, 202494444Class IIOngoingStryker Blueprint Software, Catalog #BPUE001.The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval.accessdata.fda.gov
June 25, 202188174Class IIOngoingThe Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a) Catalog # DWH039 - Diameter 39 mm Height 14 mm Eccentric LOW (1.5) Material PyC/CoCr, b) Catalog # DWH041 - Diameter 41 m m Height 15 mPotential patient exposure to the graphite substrate.accessdata.fda.gov

Compare with other makers

Updated April 3, 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.