510(k) Report

Devices descending from K191318

3 later devices reach AEQUALIS FLEX REVIVE Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+1K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+2K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501