510(k) Report

Devices descending from K962152

283 later devices reach Osteonics Scorpio Posteriorly Stabilized Total Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+4K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+4K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.20250—
+4K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+4K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+4K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+4K242746OvertureTi Knee Resurfacing SystemTMOverture Orthopaedics20240—
+4K242401EXULT Knee Replacement SystemCorentec Co., Ltd.20240—
+4K242046EXULT Knee Replacement SystemCorentec Co., Ltd.20242—
+4K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+4K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+4K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+4K220930Restoris Multi-Compartmental Knee SystemMako Surgical Corp.20220—
+4K201611Apex Knee SystemOmnilife Science20210—
+4K203341ACS LD Uni FB Knee SystemImplantcast GmbH20211—
+4K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+4K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+4K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+4K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+4K191996BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20193—
+4K191150Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20194—
+4K181302Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20197—
+4K141934Physica KR Knee SystemLima Corporate S.P.A.201518—
+4K142069GMK ExtensionMedacta International20144—
+4K133811Restoris Porous Partial Knee SystemMako Surgical Corp.201419—
+4K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+4K132640Iuni Unicondylar Knee Replacement SystemConformis, Inc.2013253
+4K131167UnivationAesculap Implant Systems, LLC201308
+4K131310GMK Full PE Tibial ComponentsMedacta International20132—
+4K130299GMK HingeMedacta International201342
+4K123380Stride Unicondylar KneeBlue Belt Technologies, Inc.2013112
+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—
+4K094050Itotal CR Knee Replacement SystemConformis, Inc.201041—
+4K093513Iduo Bicompartmental Knee Repair SystemConformis, Inc.2009173
+4K090988GMK Total Knee SystemMedacta International S.A.2009521
+4K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation2009505
+4K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+4K080936Conformis Total Knee Repiar System (Itotal) Tibial Component: 6.0 MM ThicknessConformis, Inc.20080—
+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—
+5K250889EXULT Knee Replacement SystemCorentec Co., Ltd.20250—
+5K242307ACHIEVE Partial Knee SystemIgnite Orthomotion20241—
+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—
+5K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+5K212307BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+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—
+5K203697BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20212—
+5K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+5K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+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—
+5K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+5K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+5K190633NanoOrtho NanoKnee® SystemNanoortho, LLC20190—
+5K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+5K190439Engage™ Partial Knee SystemEngage Uni, LLC201954
+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—
+5K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc.20171—
+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—
+5K150410Restoris Porous Partial Knee SystemMako Surgical Corporation20150—
+5K140826GMK Sphere ExtensionMedacta International201417—
+5K133630GMK Short StemMedacta International20131—
+5K133039Restoris Multicompartmental Knee SystemMako Surgical Corporation201326—
+5K123721GMK Revision ExtensionMedacta International20133—
+5K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201333—
+5K122991Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201226—
+5K122232GMK NarrowMedacta International20128—
+5K122033Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201226—
+5K120316Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201236—
+5K113378Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201236—
+5K120068Conformis Itotal CR Knee Replacement System (KRS)Conformis, Inc.201236—
+5K112780Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201138—
+5K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+5K103721Mpact Acetabular SystemMedacta International201121—
+5K103352Versafitcup CC TrioMedacta International20114—
+5K103117Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2011401
+5K102437GMK Revision Knee SystemMedacta International S.A.201034—
+5K093806Myknee Cutting BlocksMedacta International S.A.201016—
+6K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+6K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20260—
+6K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+6K250450Coated hip implantsMedacta International S.A.20250—