Tornier S.A.S.
Medical device manufacturer in Montbonnot-Saint-Martin, Fran.
19510(k) clearances
0PMA approvals
13recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K232265 | BLUEPRINT Patient Specific InstrumentationPHX · Traditional | 02/21/2024SE |
| K222510 | Blueprint Mixed Reality systemOLO · Traditional | 01/20/2023SE |
| K203315 | BLUEPRINT Patient Specific InstrumentationKWS · Traditional | 04/15/2021SE |
| K190521 | Aequalis Ascend Flex Shoulder SystemKWS · Special | 06/12/2019SE |
| K162800 | BLUEPRINT Patient Specific InstrumentationKWS · Traditional | 02/22/2017SE |
| K161789 | BLUEPRINT Patient Specific InstrumentationKWS · Traditional | 12/27/2016SE |
| K153452 | Salto XT, Salto TalarisHSN · Traditional | 08/11/2016SE |
| K160555 | BLUEPRINT Patient Specific InstrumentationKWS · Special | 06/10/2016SE |
| K152966 | Aequalis Fx2PHX · Special | 01/14/2016SE |
| K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisKWS · Special | 09/24/2015SE |
| K143374 | BLUEPRINT Patient Specific InstrumentationKWS · Traditional | 04/08/2015SE |
| K141345 | Aequalis FX2PHX · Traditional | 11/18/2014SE |
| K140478 | Aequalis Reversed Shoulder ProsthesisPHX · Traditional | 08/06/2014SE |
| K140082 | Aequalis(Tm) Ascent(Tm) Flex Shoulder SystemPHX · Traditional | 07/18/2014SE |
| K132285 | Aequalis Reversed Shoulder ProsthesisPHX · Traditional | 12/05/2013SE |
| K131231 | Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…PHX · Traditional | 10/16/2013SE |
| K130051 | 611 Ankle Fusion NailHSB · Traditional | 07/15/2013SE |
| K130533 | Salto Talaris Total Ankle Prosthesis, RHSHSN · Special | 05/17/2013SE |
| K122698 | Aequalis Ascend Flex Shoulder SystemKWS · Traditional | 01/08/2013SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1738-2025 Class II | Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for…A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions… | 04/10/2025Open, Classified |
| Z-1542-2025 Class II | stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder ArthroplastyStryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality… | 03/05/2025Open, Classified |
| Z-1541-2025 Class II | stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder…Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality… | 03/05/2025Open, Classified |
| Z-1540-2025 Class II | stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder…Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality… | 03/05/2025Open, Classified |
| Z-1539-2025 Class II | stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in…Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality… | 03/05/2025Open, Classified |
| Z-1538-2025 Class II | stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker…Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality… | 03/05/2025Open, Classified |
| Z-1537-2025 Class II | stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged…Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality… | 03/05/2025Open, Classified |
| Z-1536-2025 Class II | stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in…Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality… | 03/05/2025Open, Classified |
| Z-1535-2025 Class II | stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in…Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality… | 03/05/2025Open, Classified |
| Z-1534-2025 Class II | stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog…Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality… | 03/05/2025Open, Classified |
| Z-0846-2025 Class II | Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use…The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can… | 12/18/2024Open, Classified |
| Z-1883-2024 Class II | Stryker Blueprint Software, Catalog #BPUE001.The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and… | 04/16/2024Open, Classified |
| Z-2291-2021 Class II | The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a)…Potential patient exposure to the graphite substrate. | 06/25/2021Open, Classified |