510(k) Report

Devices descending from K151293

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+1K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+1K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+1K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+2K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+2K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+2K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+2K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+2K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+2K201315PERFORM Humeral System – StemTornier, Inc.2020111
+3K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+3K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+3K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+3K240876Identity Shoulder SystemZimmer, Inc.20241—
+3K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+3K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+4K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+4K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+4K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+4K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—