510(k) Report

Devices descending from K994214

121 later devices reach Gem Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+7K252847NextAR Hip PlatformMedacta International S.A.20260—
+7K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+7K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+7K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+7K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+7K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+7K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+7K211891DM Converter - TiN coatedMedacta International S.A.20220—
+7K220705MyKnee R Pin PositionersMedacta International S.A.20220—
+7K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+7K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+7K210153NextAR RSA PlatformMedacta International S.A.202151
+7K202152NextAR TKA PlatformMedacta International S.A.202011—
+8K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+8K250477NextAR (TM) SpineMedacta International S.A.20250—
+8K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+8K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+8K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+9K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+9K233172NextAR™ Spine PlatformMedacta International S.A.20241—