510(k) Report

Devices descending from K131231

5 later devices reach Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+1K141345Aequalis FX2Tornier S.A.S.201411
+2K240876Identity Shoulder SystemZimmer, Inc.20241—
+2K152966Aequalis Fx2Tornier S.A.S.201601
+3K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—