510(k) Report

Devices descending from K143552

24 later devices reach Simpliciti Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+1K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+1K213615Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.20220—
+1K212683GLOBAL ICON Stemless Shoulder SystemDepuy (Ireland)20220—
+1K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+1K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+1K183194Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20198—
+1K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp20196—
+1K173388Exactech Equinoxe Stemless ShoulderExactech, Inc.20189—
+1K171858Sidus Stem-Free ShoulderZimmer GmbH2017133
+2K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+2K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+2K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+2K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+2K243248Inhance Intact™Depuy Ireland UC20240—
+2K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.20241—
+2K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+2K221758SMR Stemless AnatomicLima Corporate S.P.A.20230—
+2K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+2K201391Easytech® Anatomical Shoulder SystemFx Shoulder USA, Inc.20210—
+2K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20201—
+2K192097Exactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc.20201—
+3K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—
+3K203100Arthrex Eclipse Titanium Humeral HeadArthrex, Inc.20200—