Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in NetherlandsLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of StrykerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Tornier with 116 510(k) clearances and 31 device recalls. The most recent is a 510(k) clearance dated Oct 28, 2026: Tornier Humeral Reconstruction System (HRS) Tuberosity Body.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 28, 2026 | Tornier Humeral Reconstruction System (HRS) Tuberosity BodyK263583 · KWS | 510(k) clearances |
| Jul 22, 2026 | Tornier Perform Advanced GlenoidK260721 · KWS | 510(k) clearances |
| Jan 8, 2026 | Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)K252788 · PHX | 510(k) clearances |
| Oct 30, 2025 | Tornier Humeral Reconstruction System Max (Tornier HRS Max)K251686 · KWT | 510(k) clearances |
| Apr 10, 2025 | Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.Class II · A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the soft | Device recalls |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Class II · Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrum | Device recalls |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, CatalClass II · Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrum | Device recalls |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder ArthroplastyClass II · Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrum | Device recalls |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder ArthroplastyClass II · Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrum | Device recalls |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog NumberClass II · Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrum | Device recalls |
| Mar 5, 2025 | stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in stryker Blueprint MixedClass II · Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrum | Device recalls |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Class II · Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrum | Device recalls |
| Feb 21, 2024 | BLUEPRINT™ Patient Specific InstrumentationK232265 · PHX | 510(k) clearances |
| Oct 31, 2023 | Tornier Humeral Nail and Tornier Long Humeral NailK230352 · HSB | 510(k) clearances |
| Jan 20, 2023 | Blueprint Mixed Reality systemK222510 · OLO | 510(k) clearances |
| Dec 16, 2022 | Tornier Pyrocarbon Humeral HeadDEN220012 · QKW | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
