510(k) Report

Devices descending from K994128

139 later devices reach Scorpio Total Stablizer (TS) Total Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+6K183582MPACT ExtensionMedacta International S.A.20194—
+6K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+6K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+6K143453Mpact Double Mobility SystemMedacta International20151—
+6K132879Mpact ExtensionMedacta International201411—
+6K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+6K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+6K131458Mpact DM Liner ConverterMedacta International20133—
+6K122911Versafitcup CC Trio ExtensionMedacta International20121—
+6K122641Mpact ExtensionMedacta International201214—
+6K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+6K111145Endo HeadMedacta International20110—
+7K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+7K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+7K252847NextAR Hip PlatformMedacta International S.A.20260—
+7K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+7K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+7K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+7K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+7K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+7K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+7K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+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—
+8K250477NextAR (TM) SpineMedacta International S.A.20250—
+8K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+8K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+8K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+8K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+8K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+8K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+9K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+9K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+9K233172NextAR™ Spine PlatformMedacta International S.A.20241—