510(k) Report

Devices descending from K121416

20 later devices reach GMK Sphere through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+1K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+1K211664GMK Sphere RevisionMedacta International S.A.20210—
+1K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+1K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+1K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+1K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+1K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+1K162035GMK SphereMedacta International S.A.201710—
+1K142069GMK ExtensionMedacta International20144—
+1K140826GMK Sphere ExtensionMedacta International201417—
+1K133630GMK Short StemMedacta International20131—
+2K262057GMK ExtensionMedacta International SA20260—
+2K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+2K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+2K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+2K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+2K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+3K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+3K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—