Company · FR
Tornier S.A.S.
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2024. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
13recalls (0 in 12 months)
12recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | 11 |
| PHX | Shoulder Prosthesis, Reverse Configuration | 9 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 8 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 2 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 |
| QHE | Shoulder Arthroplasty Implantation System | 1 |
| QKW | Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 21, 2024 | K232265 | BLUEPRINT Patient Specific Instrumentation Tornier S.A.S., FR | PHX |
| Jan 20, 2023 | K222510 | Blueprint Mixed Reality system Tornier S.A.S., FR | OLO |
| Dec 16, 2022 | DEN220012 | Tornier Pyrocarbon Humeral Head Tornier S.A.S., FR | QKW |
| Apr 15, 2021 | K203315 | BLUEPRINT Patient Specific Instrumentation Tornier S.A.S., FR | KWS |
| Jun 12, 2019 | K190521 | Aequalis Ascend Flex Shoulder System Tornier S.A.S., FR | KWS |
| Feb 22, 2017 | K162800 | BLUEPRINT Patient Specific Instrumentation Tornier S.A.S., FR | KWS |
| Dec 27, 2016 | K161789 | BLUEPRINT Patient Specific Instrumentation Tornier S.A.S., FR | KWS |
| Aug 11, 2016 | K153452 | Salto XT, Salto Talaris Tornier S.A.S., FR | HSN |
| Jun 10, 2016 | K160555 | BLUEPRINT Patient Specific Instrumentation Tornier S.A.S., FR | KWS |
| Jan 14, 2016 | K152966 | Aequalis Fx2 Tornier S.A.S., FR | PHX |
| Sep 24, 2015 | K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis Tornier S.A.S., FR | KWS |
| Apr 8, 2015 | K143374 | BLUEPRINT Patient Specific Instrumentation Tornier S.A.S., FR | KWS |
| Nov 18, 2014 | K141345 | AEQUALIS FX2 Tornier S.A.S., FR | PHX |
| Aug 6, 2014 | K140478 | AEQUALIS REVERSED SHOULDER PROSTHESIS Tornier S.A.S., FR | PHX |
| Jul 18, 2014 | K140082 | AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM Tornier S.A.S., FR | PHX |
| Dec 5, 2013 | K132285 | AEQUALIS REVERSED SHOULDER PROSTHESIS Tornier S.A.S., FR | PHX |
| Oct 16, 2013 | K131231 | AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS Tornier S.A.S., FR | PHX |
| Jul 15, 2013 | K130051 | 611 ANKLE FUSION NAIL Tornier S.A.S., FR | HSB |
| May 17, 2013 | K130533 | SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS Tornier S.A.S., FR | HSN |
| Jan 8, 2013 | K122698 | AEQUALIS ASCEND FLEX SHOULDER SYSTEM Tornier S.A.S. | KWS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 8, 2025 | Tornier S.A.S. Blueprint Software, BPUE001.
Intended for use by surgeons as a pre surgical planner for shoulder replacement. Open, Classified |
PHX | K211359 |
| Apr 8, 2025 | Tornier S.A.S. stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty Open, Classified |
OLO | K222510 |
| Apr 8, 2025 | Tornier S.A.S. stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty Open, Classified |
OLO | K222510 |
| Apr 8, 2025 | Tornier S.A.S. stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty Open, Classified |
OLO | K222510 |
| Apr 8, 2025 | Tornier S.A.S. stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty Open, Classified |
OLO | K222510 |
| Apr 8, 2025 | Tornier S.A.S. stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty Open, Classified |
OLO | K222510 |
| Apr 8, 2025 | Tornier S.A.S. stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty Open, Classified |
OLO | K222510 |
| Apr 8, 2025 | Tornier S.A.S. stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty Open, Classified |
OLO | K222510 |
| Apr 8, 2025 | Tornier S.A.S. stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty Open, Classified |
OLO | K222510 |
| Apr 8, 2025 | Tornier S.A.S. 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 Shoul Open, Classified |
OLO | K222510 |
| Jan 10, 2025 | Tornier S.A.S. Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200.
Indicated for use during Total Shoulder Arthroplasty. Open, Classified |
OLO | K222510 |
| May 22, 2024 | Tornier S.A.S. Stryker Blueprint Software, Catalog #BPUE001. Open, Classified |
PHX | K211359 |
| Jun 25, 2021 | Tornier S.A.S. 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 - Dia Open, Classified |
QHE | None listed |