Tornier S.A.S.
Montbonnot Saint-Martin Isere, FR
TORNIER S.A.S appears in FDA device records in Montbonnot Saint-Martin Isere, FR. FDA records list 20 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 13 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 20 510(k) clearances for Tornier S.A.S. between 2013 and 2024. The busiest year on record is 2013, with 5. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 5 |
| 2014 | 3 |
| 2015 | 2 |
| 2016 | 4 |
| 2017 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232265 | BLUEPRINT™ Patient Specific Instrumentation | PHX | Substantially Equivalent | |
| K222510 | Blueprint Mixed Reality system | OLO | Substantially Equivalent | |
| DEN220012 | Tornier Pyrocarbon Humeral Head | QKW | Unknown | |
| K203315 | BLUEPRINT™ Patient Specific Instrumentation | KWS | Substantially Equivalent | |
| K190521 | Aequalis Ascend Flex Shoulder System | KWS | Substantially Equivalent | |
| K162800 | BLUEPRINT Patient Specific Instrumentation | KWS | Substantially Equivalent | |
| K161789 | BLUEPRINT Patient Specific Instrumentation | KWS | Substantially Equivalent | |
| K153452 | Salto XT, Salto Talaris | HSN | Substantially Equivalent | |
| K160555 | BLUEPRINT Patient Specific Instrumentation | KWS | Substantially Equivalent | |
| K152966 | Aequalis Fx2 | PHX | Substantially Equivalent | |
| K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis | KWS | Substantially Equivalent | |
| K143374 | BLUEPRINT Patient Specific Instrumentation | KWS | Substantially Equivalent | |
| K141345 | AEQUALIS FX2 | PHX | Substantially Equivalent | |
| K140478 | AEQUALIS REVERSED SHOULDER PROSTHESIS | PHX | Substantially Equivalent | |
| K140082 | AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM | PHX | Substantially Equivalent | |
| K132285 | AEQUALIS REVERSED SHOULDER PROSTHESIS | PHX | Substantially Equivalent | |
| K131231 | AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS | PHX | Substantially Equivalent | |
| K130051 | 611 ANKLE FUSION NAIL | HSB | Substantially Equivalent | |
| K130533 | SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS | HSN | Substantially Equivalent | |
| K122698 | AEQUALIS ASCEND FLEX SHOULDER SYSTEM | KWS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008388276 | 3008388276 | TORNIER S.A.S | 176 RUE LAVOISIER, Montbonnot Saint-Martin Isere 38330 FR | 2026 | |
| 3003902387 | 3003902387 | TORNIER, SAS | PARC POLYTEC, GRENOBLE CEDEX 1 Isere 38024 FR | 2026 | |
| 3000931034 | 3000931034 | Tornier S.A.S. | 161 rue Lavoisier, Montbonnot Saint-Martin Isere 38330 FR | 2026 | and 35 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HWJAwl
- HTWBit, Drill
- GFGBit, Surgical
- GFABlade, Saw, General & Plastic Surgery, Surgical
- HTQBroach
- LZNCement Obturator
- HXDClamp
- HTFCurette
- HTEElevator
- HWBExtractor
- HTDForceps
- HTJGauge, Depth
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- HWAImpactor
- HWNInstrument, Compression
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- FTMMesh, Surgical
- JDZMixer, Cement, For Clinical Use
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- HWQPasser
- HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- JDCProsthesis, Elbow, Constrained, Cemented
- KWIProsthesis, Elbow, Hemi-, Radial, Polymer
- JDBProsthesis, Elbow, Semi-Constrained, Cemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- PAOProsthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
- KYIProsthesis, Wrist, Carpal Trapezium
- LRYPunch, Surgical
- HXOPusher, Socket
- HTRRasp
- HTOReamer
- GADRetractor
- HSBRod, Fixation, Intramedullary And Accessories
- GDRSaw, Manual And Accessories
- HXXScrewdriver
- QHEShoulder Arthroplasty Implantation System
- QKWShoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis
- PHXShoulder Prosthesis, Reverse Configuration
- HWXTap, Bone
- HWTTemplate
- FSMTray, Surgical, Instrument
- HXCWrench
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1738-2025 | Blueprint 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. | Class II | Open, Classified | |
| Z-1542-2025 | stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty | Stryker 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 general difficulties using the product. | Class II | Open, Classified | |
| Z-1541-2025 | stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty | Stryker 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 general difficulties using the product. | Class II | Open, Classified | |
| Z-1540-2025 | stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty | Stryker 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 general difficulties using the product. | Class II | Open, Classified | |
| Z-1539-2025 | stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty | Stryker 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 general difficulties using the product. | Class II | Open, Classified | |
| Z-1538-2025 | stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty | Stryker 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 general difficulties using the product. | Class II | Open, Classified | |
| Z-1537-2025 | stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty | Stryker 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 general difficulties using the product. | Class II | Open, Classified | |
| Z-1536-2025 | stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty | Stryker 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 general difficulties using the product. | Class II | Open, Classified | |
| Z-1535-2025 | stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty | Stryker 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 general difficulties using the product. | Class II | Open, Classified | |
| Z-1534-2025 | stryker 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 Arthroplasty | Stryker 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 general difficulties using the product. | Class II | Open, Classified | |
| Z-0846-2025 | Stryker 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. | Class II | Open, Classified | |
| Z-1883-2024 | Stryker 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. | Class II | Open, Classified | |
| Z-2291-2021 | The 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 mm Eccentric LOW (1.5) Material PyC/CoCr, c) Catalog # DWH043 - Diameter 43 mm Height 16 mm Eccentric LOW (1.5) Material PyC/CoCr, d) Catalog # DWH046 - Diameter 46 mm Height 17 mm Eccentric LOW (1.5) Material PyC/CoCr, e) Catalog # DWH048 - Diameter 48 mm Height 18 mm Eccentric LOW (1.5) Material PyC/CoCr, f) Catalog # DWH050 - Diameter 50 mm Height 16 mm Eccentric LOW (1.5) Material PyC/CoCr, g) Catalog # DWH051 - Diameter 50 mm Height 19 mm Eccentric LOW (1.5) Material PyC/CoCr, h) Catalog # DWH052 - Diameter 52 mm Height 19 mm Eccentric LOW (1.5) Material PyC/CoCr, i) Catalog # - DWH053 - Diameter 52 mm Height 23 mm Eccentric LOW (1.5) Material PyC/CoCr, j) Catalog # DWH054 - Diameter 54 mm Height 23 mm Eccentric LOW (1.5) Material PyC/CoCr, k) Catalog # DWH139 - Diameter 39 mm Height 14 mm Eccentric HIGH (3.5) Material PyC/CoCr, l) Catalog # DWH141 - Diameter 41 mm Height 15 mm Eccentric HIGH (3.5) Material PyC/CoCr, m) Catalog # DWH143 - Diameter 43 mm Height 16 mm Eccentric HIGH (3.5) Material PyC/CoCr, n) Catalog # DWH146 - 46 mm Height 17 mm Eccentric HIGH (4) Material PyC/CoCr, o) Catalog # DWH148, - Diameter 48 mm Height 18 mm Eccentric HIGH (4) Material PyC/CoCr, p) Catalog # DWH150 - Diameter 50 mm Height 16 mm Eccentric HIGH (4) Material PyC/CoCr, q) Catalog # DWH151 - Diameter 50 mm Height 19 mm Eccentric HIGH (4) Material PyC/CoCr, r) Catalog # DWH152 - Diameter 52 mm Height 19 mm Eccentric HIGH (4) Material PyC/CoCr, s) Catalog # DWH153 - Diameter 52 mm Height 23 mm Eccentric HIGH (4) Material PyC/CoCr, t) Catalog # DWH154 - Diameter 54 mm Height 23 mm Eccentric HIGH (4) Material PyC/CoCr, | Potential patient exposure to the graphite substrate. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain