510(k) Report

Devices descending from K041549

218 later devices reach Zimmer Trabecular Metal Humeral Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+7K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+8K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+8K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+8K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+8K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+8K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+8K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+8K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+8K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+8K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+8K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+8K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+8K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+8K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+9K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+9K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+9K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—