510(k) Report

Devices descending from K031218

7 later devices reach Modification to Tornier Total Elbow Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100562Latitude Elbow ProsthesisTornier, Inc.201052
+1K070787Latitude Elbow ProthesisTornier20076—
+2K181362TEMA Elbow SystemLima Corporate S.P.A.201911
+2K182461LATITUDE EV Total Elbow ArthroplastyTornier, Inc.20181—
+2K171010Latitude EV Total Elbow ArthroplastyTornier, Inc.20174—
+3K222807TEMA Elbow system - Line extensionLima Corporate S.P.A.202201
+3K193247LATITUDE EV™ Total Elbow ArthroplastyTornier, Inc.20200—