510(k) Report

Devices descending from K955099

11 later devices reach Sorbie Total Elbow System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050848Tornier Elbow ProsthesisTornier20057—
+1K031218Modification to Tornier Total Elbow ProsthesisTornier20037—
+1K972691Abc Total Elbow ProthesisBiomet, Inc.19971—
+2K100562Latitude Elbow ProsthesisTornier, Inc.201052
+2K070787Latitude Elbow ProthesisTornier20076—
+2K983036Single Axle Total ElbowBiomet, Inc.19990—
+3K181362TEMA Elbow SystemLima Corporate S.P.A.201911
+3K182461LATITUDE EV Total Elbow ArthroplastyTornier, Inc.20181—
+3K171010Latitude EV Total Elbow ArthroplastyTornier, Inc.20174—
+4K222807TEMA Elbow system - Line extensionLima Corporate S.P.A.202201
+4K193247LATITUDE EV™ Total Elbow ArthroplastyTornier, Inc.20200—