510(k) Report

Devices descending from K980502

3 later devices reach Osteonics Total Elbow System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181362TEMA Elbow SystemLima Corporate S.P.A.201911
+1K983036Single Axle Total ElbowBiomet, Inc.19990—
+2K222807TEMA Elbow system - Line extensionLima Corporate S.P.A.202201