510(k) Report

Devices descending from K201315

11 later devices reach PERFORM Humeral System – Stem through their predicates, nearest generation first.

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