510(k) Report

Devices descending from K020114

143 later devices reach 3D KNEE through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+1K143242Rebel 3DKNEE SystemEncore Medical L.P.20151117
+1K122239Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn Coating…Encore Medical L.P.201320—
+1K121835Domed Tri-Peg Patella, Highly Cross Linked Domed Tri-Peg Patella with VEEncore Medical L.P.20120—
+1K091956Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Encore Medical L.P.20101194
+1K100900Motivation Knee SystemEncore Medical L.P.2010724
+1K0329053DKNEE Porous Coated Femoral ComponentEncore Orthopedics, Inc.20042—
+2K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20260—
+2K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+2K241180Consensus Knee System with TiNbNShalby Advanced Technologies20251—
+2K201611Apex Knee SystemOmnilife Science20210—
+2K200912Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc.20202—
+2K182872LINK GEMINI SL Total Knee SystemWaldemar Link GmbH & Co. KG20198—
+2K173723EMPOWR Universal Tibial BaseplateEncore Medical L.P.201821
+2K171991EMPOWR Porous Knee SystemEncore Medical L.P.201713
+2K170573Empowr CR Knee Tibial InsertEncore Medical L.P.20170—
+2K160342EMPOWR PS Knee SystemEncore Medical L.P.201665
+2K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx…Waldemar Link GmbH & Co. KG2016916
+2K140830Exprt Revision KneeEncore Medical L.P.201471
+2K131337Balanced Knee System High Flex Vitamin E PS Tibial Insert and PatellaOrtho Development Corp.20133—
+2K130365X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P.201338—
+2K123982Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+Encore Medical L.P.201335—
+2K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201333—
+2K121727Movation Knee SystemEncore Medical L.P.201214—
+2K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+2K113756Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly…Encore Medical L.P.2012351
+2K103223Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P.201037—
+3K233093Balanced Knee® System TriMax PS Plus Tibial InsertOrtho Development Corporation20230—
+3K220628LINK Endo-Model EVO Knee SystemWaldemar Link GmbH & Co. KG20220—
+3K213793EMPOWR Revision KneeEncore Medical L.P.20221—
+3K212839Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd.20211—
+3K212742GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK…Waldemar Link GmbH & Co. KG2021122
+3K211768LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPEWaldemar Link GmbH & Co. KG20210—
+3K202924LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG2021211
+3K210308EMPOWR Porous Femur with HAnano SurfaceTMEncore Medical L.P.20210—
+3K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+3K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+3K191755SPAR-K Instruments (for use with Gemini SL Total Knee System)Waldemar Link GmbH & Co. KG20190—
+3K190057DJO Acetabular SystemEncore Medical L.P.201925
+3K180930Empowr VVC Tibial InsertEncore Medical L.P.201831
+3K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+3K172651FMP Extended LinersEncore Medical L.P.20173—
+3K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+3K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+3K161945EXPRT Revision Knee Femoral Augment (5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.20160—
+3K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+3K152169Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial InsertsOrtho Development Corporation20151—
+3K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+3K140130X-Alt Highly Cross Linked Acetabular Liners with Vitamin E, Neutral, 10 Degree Hooded…Encore Medical L.P.20141—
+3K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+3K141006RSP Humeral Socket InsertDjo Global2014212
+3K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+3K133560Itotal Cruciate Retaining Knee Replacment SystemConformis, Inc.20140—
+3K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201330—
+3K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.201330—
+3K123692Pipeline Knee SystemPipeline Orthopedics20130—
+3K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132—
+4K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.20250—
+4K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+4K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+4K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+4K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+4K230169EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial InsertEncore Medical, L.P Dba Enovis20232—
+4K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+4K230441EMPOWR Stem Extender, 50mmEncore Medical, L.P Dba Enovis20230—
+4K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+4K222816Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd.20220—
+4K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+4K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+4K211664GMK Sphere RevisionMedacta International S.A.20210—
+4K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+4K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+4K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+4K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+4K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+4K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+4K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+4K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+4K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+4K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+4K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+4K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+4K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+4K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+4K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+4K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+4K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+4K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2014251
+4K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+5K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)Encore Medical L.P.20250—
+5K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P.20250—
+5K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+5K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+5K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+5K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+5K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+5K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+5K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+5K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—