510(k) Report

Devices descending from K190521

12 later devices reach Aequalis Ascend Flex Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201315PERFORM Humeral System – StemTornier, Inc.2020111
+2K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+2K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+2K240876Identity Shoulder SystemZimmer, Inc.20241—
+2K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+2K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+2K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+3K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+3K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+3K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+3K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+3K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—