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
+1K243817Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202522
+1K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+1K160157LOSPA Modular Knee SystemCorentec Co., Ltd.201682
+1K113060Unity Toatal Knee SystemCorin USA201283
+1K030367Columbus (PS)Aesculap, Inc.2003171
+1K021313Search Evolution Total Knee SystemAesculap, Inc.2002120—
+2K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd.20260—
+2K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+2K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+2K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202501
+2K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+2K240875Unity Knee PS-C Tibial InsertCorin U.S.A. Limited20240—
+2K222278LOSPA TKR System Instrumentation, EXULT TKR System InstrumentationCorentec Co., Ltd.20220—
+2K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+2K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202—
+2K192507LOSPA II Knee SystemCorentec Co., Ltd.20197—
+2K183533Unity Total Knee SystemCorin U.S.A. Limited20191—
+2K173884Unity Total Knee SystemCorin U.S.A. Limited20182—
+2K170808Unity Total Knee SystemCorin U.S.A. Limited20170—
+2K143106VEGA Knee SystemAesculap Implant Systems, LLC20144—
+2K083772Columbus Revision Knee SystemAesculap Implant System, Inc.2009124
+2K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.200779—
+2K071220Columbus Total Knee System asAesculap Implant Systems, Inc.200771
+2K032108Search Evolution (LC) Total Knee System (Porous Coated)Aesculap, Inc.200480—
+2K023788Columbus (CR) Total Knee SystemAesculap, Inc.200225—
+2K022672Columbus Total Knee System (CR)Aesculap, Inc.2002961
+3K242401EXULT Knee Replacement SystemCorentec Co., Ltd.20240—
+3K242046EXULT Knee Replacement SystemCorentec Co., Ltd.20242—
+3K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+3K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+3K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC20153—
+3K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC20124—
+3K122985Columbus Revision Knee SystemAesculap Implant System, Inc.201201
+3K101815Enduro Knee SystemAesculap Implant Systems201010—
+3K081023Evolis Total Knee SystemMedacta International S.A.2008781
+3K081293Univation Unicondylar Knee SystemAesculap Implant Systems, Inc.200818
+3K071499Columbus Total Knee System Mios CR/PS Tibial TrayAesculap Implant Systems, Inc.20076—
+3K053579Columbus Ultra Congruent (UC) Tibial Insert/Gliding SurfaceAesculap, Inc.20060—
+3K053390Columbus (CR) Total Knee SystemAesculap, Inc.200651
+3K033260AequosAap Implantate AG200419—
+4K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+4K250889EXULT Knee Replacement SystemCorentec Co., Ltd.20250—
+4K201611Apex Knee SystemOmnilife Science20210—
+4K141934Physica KR Knee SystemLima Corporate S.P.A.201518—
+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—
+5K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+5K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+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—
+5K201084Physica systemLima Corporate S.P.A.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—
+5K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+5K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+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—
+5K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+5K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+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—
+6K253328GMK 3D Metal Tibial Tray ExtensionMedacta 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—
+6K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.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—
+6K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+6K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+6K213381Physica systemLima Corporate S.P.A.202101
+6K211938Physica LMC Knee SystemLimacorporate20210—
+6K200391MPACT ExtensionMedacta International S.A.20210—
+6K210554Physica systemLima Corporate S.P.A.20212—
+6K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+6K193559NextAR TKA PlatformMedacta Inernational SA202012—