Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Tornier, Inc.

FDA 510(k) & PMA Approved Devices — 19 products

Total Devices19
Categories8
Latest FDA decision2026-07-22
TypeNumberDevice NameCodeDateActions
510(k) K260721 Tornier Perform Advanced GlenoidKWS2026-07-22 View
510(k) K252788 Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)PHX2026-01-08 View
510(k) K251686 Tornier Humeral Reconstruction System Max (Tornier HRS Max)KWT2025-10-30 View
510(k) K230352 Tornier Humeral Nail and Tornier Long Humeral NailHSB2023-10-31 View
510(k) K220914 Tornier Perform Humeral System – FracturePHX2022-10-14 View
510(k) K220418 Tornier Perform Humeral System – StemlessPKC2022-09-14 View
510(k) K211359 Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific InstrumentationPHX2021-11-12 View
510(k) K213124 Tomier Perform™ Reversed Glenoid Cannulated GlenospheresPHX2021-10-26 View
510(k) K201315 PERFORM Humeral System – StemPAO2020-09-11 View
510(k) K193247 LATITUDE EV™ Total Elbow ArthroplastyJDB2020-08-05 View
510(k) K191711 ORTHOLOC™ SPS Shoulder Plating SystemHRS2019-07-17 View
510(k) K191318 AEQUALIS FLEX REVIVE Shoulder SystemKWS2019-06-14 View
510(k) K183696 Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidPHX2019-01-30 View
510(k) K182461 LATITUDE EV Total Elbow ArthroplastyJDB2018-12-27 View
510(k) K181587 ORTHOLOC SPS Shoulder Plating SystemHRS2018-10-05 View
510(k) K181420 Aequalis Flex Revive Shoulder SystemKWS2018-09-20 View
510(k) K171010 Latitude EV Total Elbow ArthroplastyJDB2017-08-31 View
510(k) K161742 Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidPHX2016-11-15 View
510(k) K160975 Aequalis PerFORM+ Shoulder SystemKWS2016-06-10 View

Related Clinical Trials

NCT05500066Tornier HRS (Humeral Reconstruction System) Study (REVIVE)ENROLLING_BY_INVITATIONNCT05773352Perform® Humeral System - Fracture Study (PFX)ACTIVE_NOT_RECRUITINGNCT07764614Tornier Perform™ Reversed Monopost StudyNOT_YET_RECRUITING
↑