510(k) Report

Devices descending from K923277

238 later devices reach Foundation Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182872LINK GEMINI SL Total Knee SystemWaldemar Link GmbH & Co. KG20198—
+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—
+1K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132—
+1K100900Motivation Knee SystemEncore Medical L.P.2010724
+1K090705Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp.2009421
+1K0201143D KNEEEncore Orthopedics, Inc.20021435
+1K000666TC-Plus Solution KneePlus Orthopedics20001159
+1K970031Foundation Knee System Tibial ComponentEncore Orthopedics, Inc.199702
+1K964008Foundation Knee SystemEncore Orthopedics, Inc.199621—
+1K963028Tibial InsertEncore Orthopedics, Inc.19960—
+2K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20260—
+2K241180Consensus Knee System with TiNbNShalby Advanced Technologies20251—
+2K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+2K212742GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK…Waldemar Link GmbH & Co. KG2021122
+2K202924LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG2021211
+2K200912Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc.20202—
+2K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+2K191755SPAR-K Instruments (for use with Gemini SL Total Knee System)Waldemar Link GmbH & Co. KG20190—
+2K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+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
+2K152169Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial InsertsOrtho Development Corporation20151—
+2K140830Exprt Revision KneeEncore Medical L.P.201471
+2K132752Ultracongruent InsertUnited Orthopedic Corporation20145—
+2K121727Movation Knee SystemEncore Medical L.P.201214—
+2K121835Domed Tri-Peg Patella, Highly Cross Linked Domed Tri-Peg Patella with VEEncore Medical L.P.20120—
+2K113756Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly…Encore Medical L.P.2012351
+2K112906Klassic Knee SystemTotal Joint Orthopedics, Inc.201233—
+2K091956Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Encore Medical L.P.20101194
+2K072858TC-Plus Primary Knee SystemSmith & Nephew, Inc.20075315
+2K0329053DKNEE Porous Coated Femoral ComponentEncore Orthopedics, Inc.20042—
+2K023416Modification to VKS Knee SystemPlus Orthopedics20020—
+2K022204VKS Knee SystemPlus Orthopedics2002704
+2K011258TC-Plus Porous Femoral ComponentsPlus Orthopedics200154—
+3K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.20250—
+3K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+3K243991Klassic Knee System - Revision Tibial BaseplateTotal Joint Othopedics, Inc.20251—
+3K232414Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-PostTotal Joint Othopedics, Inc.20230—
+3K230537Klassic Knee Revision SystemTotal Joint Othopedics, Inc.20232—
+3K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+3K222700Tibial baseplate, Tibial insertUnited Orthopedic Corporation20220—
+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—
+3K211602Klassic Knee SystemTotal Joint Orthopedics, Inc.20210—
+3K211768LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPEWaldemar Link GmbH & Co. KG20210—
+3K201611Apex Knee SystemOmnilife Science20210—
+3K210308EMPOWR Porous Femur with HAnano SurfaceTMEncore Medical L.P.20210—
+3K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+3K183596Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post…Total Joint Orthopedics, Inc.20192—
+3K180930Empowr VVC Tibial InsertEncore Medical L.P.201831
+3K180159Klassic® Knee SystemTotal Joint Orthopedics, Inc.201822—
+3K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation20171—
+3K162422Klassic Knee SystemTotal Joint Orthopedics, Inc.201623—
+3K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc.20160—
+3K161945EXPRT Revision Knee Femoral Augment (5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.20160—
+3K152430All Poly Tibial ComponentUnited Orthopedic Corporation20160—
+3K153310Klassic Knee SystemTotal Joint Orthopedics, Inc.201524—
+3K153075Klassic Knee SystemTotal Joint Orthopedics, Inc.201524—
+3K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation20153—
+3K150105Klassic Knee System-Sombrero PatellaTotal Joint Orthopedics, Inc.201524—
+3K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc.201427—
+3K131337Balanced Knee System High Flex Vitamin E PS Tibial Insert and PatellaOrtho Development Corp.20133—
+3K130365X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P.201338—
+3K123982Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+Encore Medical L.P.201335—
+3K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201333—
+3K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+3K113482Journey II Deep Dished Articular InsertsSmith & Nephew, Inc.20126—
+3K103223Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P.201037—
+3K090988GMK Total Knee SystemMedacta International S.A.2009521
+3K053579Columbus Ultra Congruent (UC) Tibial Insert/Gliding SurfaceAesculap, Inc.20060—
+3K032215VKS/TC-Plus Revision KneePlus Orthopedics20036—
+4K262057GMK ExtensionMedacta International SA20260—
+4K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—
+4K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+4K233093Balanced Knee® System TriMax PS Plus Tibial InsertOrtho Development Corporation20230—
+4K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+4K230169EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial InsertEncore Medical, L.P Dba Enovis20232—
+4K230441EMPOWR Stem Extender, 50mmEncore Medical, L.P Dba Enovis20230—
+4K222816Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd.20220—
+4K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+4K211877Klassic Knee SystemTotal Joint Orthopedics, Inc.20221—
+4K211671Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc.20211—
+4K211664GMK Sphere RevisionMedacta International S.A.20210—
+4K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation20210—
+4K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+4K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+4K202740Klassic Knee System Tibial Inserts, PS-MaxTotal Joint Orthopedics, Inc.20200—
+4K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+4K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+4K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+4K190057DJO Acetabular SystemEncore Medical L.P.201925
+4K190280Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System -…Total Joint Orthopedics, Inc.20190—
+4K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+4K172651FMP Extended LinersEncore Medical L.P.20173—
+4K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—