510(k) Report

Devices descending from K974556

192 later devices reach Osteonics Scorpio Posterior Cruciate Retaining Total Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K142069GMK ExtensionMedacta International20144—
+4K131167UnivationAesculap Implant Systems, LLC201308
+4K131310GMK Full PE Tibial ComponentsMedacta International20132—
+4K130299GMK HingeMedacta International201342
+4K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+4K121416GMK SphereMedacta International201220—
+4K120790GMK - Line ExtensionMedacta International201211—
+4K113571GMK Resufacing Patella Size 4Medacta International201223—
+4K111283GMK Revision Hybrid LinersMedacta International20110—
+4K090988GMK Total Knee SystemMedacta International S.A.2009521
+4K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+5K262057GMK ExtensionMedacta International SA20260—
+5K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+5K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+5K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+5K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+5K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+5K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+5K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+5K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+5K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+5K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+5K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+5K211664GMK Sphere RevisionMedacta International S.A.20210—
+5K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+5K210062Mectaplug PE IIMedacta International S.A.20210—
+5K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+5K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+5K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+5K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+5K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+5K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+5K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+5K162035GMK SphereMedacta International S.A.201710—
+5K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+5K140826GMK Sphere ExtensionMedacta International201417—
+5K133630GMK Short StemMedacta International20131—
+5K123721GMK Revision ExtensionMedacta International20133—
+5K122232GMK NarrowMedacta International20128—
+5K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+5K103721Mpact Acetabular SystemMedacta International201121—
+5K103352Versafitcup CC TrioMedacta International20114—
+5K102437GMK Revision Knee SystemMedacta International S.A.201034—
+5K093806Myknee Cutting BlocksMedacta International S.A.201016—
+6K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+6K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+6K250450Coated hip implantsMedacta International S.A.20250—
+6K241461Mpact Constrained LinerMedacta International S.A.20251—
+6K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+6K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+6K230011Mpact ExtensionMedacta International S.A.20233—
+6K231037MyKnee UNI-STMedacta International S.A.20230—
+6K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+6K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+6K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+6K200391MPACT ExtensionMedacta International S.A.20210—
+6K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+6K193559NextAR TKA PlatformMedacta Inernational SA202012—
+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—
+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—