Tornier, Inc. FDA Approvals

0 new drug approvals and 8 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Tornier Perform Advanced Glenoid510(k)Jul 22, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 22, 2026
Tornier Perform Reversed Monopost Glenoid (Perform Mono)510(k)Jan 8, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 8, 2026
Tornier Humeral Reconstruction System Max (Tornier HRS Max)510(k)Oct 30, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Oct 30, 2025
Tornier Humeral Nail and Tornier Long Humeral Nail510(k)Oct 31, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Oct 31, 2023
Tornier Perform Humeral System Fracture510(k)Oct 14, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Oct 14, 2022
Tornier Perform Humeral System Stemless510(k)Sep 14, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 14, 2022
Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient Specific Instrumentation510(k)Nov 12, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 12, 2021
Tomier Perform Reversed Glenoid Cannulated Glenospheres510(k)Oct 26, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Oct 26, 2021