510(k) Report

FDA applicant

Stryker Corporation (Tornier, Inc.)

Bloomington, MN5 decisions2024–20260 recalls

FDA records 5 decisions for Stryker Corporation (Tornier, Inc.) (Bloomington, MN) from 2024 to 2026: 5 510(k) clearances. Most are in product codes PHX (Shoulder Prosthesis, Reverse Configuration) and KWS (Prosthesis, Shoulder, Semi-Constrained…). Since 2016 its 510(k)s took a median of 139 days from receipt to decision, against 130 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Stryker Corporation (Tornier, S.A.S.)”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Stryker Corporation (Tornier, Inc.)’s devices, and how often a recall has named them.

FDA decisions per year

3in 2024

2024: 32026 (partial year): 2
2024high 3 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Stryker Corporation (Tornier, Inc.) by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PHXShoulder Prosthesis, Reverse Configuration3decisions
  • KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented2decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 139 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 130 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, Inc.) · 20241cites it
  • K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.) · 20241cites it

What has FDA decided for it lately?

  • K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.) · 2026
  • K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.) · 2026
  • K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, Inc.) · 2024
  • K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.) · 2024
  • K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.) · 2024

All 3 as Stryker Corporation (Tornier, Inc.) →All 2 as Stryker Corporation (Tornier, S.A.S.) →

Other applicant names beginning “Stryker”

FDA records each applicant name separately; these may or may not be the same firm.

Stryker Corp. 354Stryker Endoscopy 103Stryker Instruments 77Stryker Spine 76Stryker Leibinger GmbH & Co KG 36Stryker Neurovascular 36Stryker Sustainability Solutions 34Stryker Trauma AG 32Stryker Orthopaedics 24Stryker Medical 14Stryker Instruments, Instruments Div. 6Stryker Corporate 6