510(k) K222510 ยท OLO Orthopedic Stereotaxic Instrument
Blueprint Mixed Reality system
| Applicant | Tornier S.A.S., Montbonnot-Saint-Martin, FR |
| Decision | Substantially Equivalent, Jan 20, 2023 |
| Received | Aug 19, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222510
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Apr 8, 2025 | Tornier S.A.S. stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty Open, Classified |
OLO | None listed |
| Apr 8, 2025 | Tornier S.A.S. stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty Open, Classified |
OLO | None listed |
| Apr 8, 2025 | Tornier S.A.S. stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty Open, Classified |
OLO | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.