510(k) Report

Devices descending from K162035

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+2K262057GMK ExtensionMedacta International SA20260—
+2K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+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—
+3K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+4K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—