510(k) Report

Devices descending from K933494

108 later devices reach Exactech Posterior Stabilized Cemented Total Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100900Motivation Knee SystemEncore Medical L.P.2010724
+1K093360Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes 2.5F/1.5T-3.5F/4.5TExactech, Inc.2010152
+1K032606Optetrak Total Knee System Asymmetric Femoral Components Size 6 Psoterior-Stabilizing…Exactech, Inc.200318—
+1K011976Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc.2001107—
+2K173723EMPOWR Universal Tibial BaseplateEncore Medical L.P.201821
+2K160342EMPOWR PS Knee SystemEncore Medical L.P.201665
+2K153776Optetrak One Logic Femoral ComponentsExactech, Inc.20164—
+2K152170Exactech Optetrak Logic Enhanced AssemblyExactech, Inc.201523
+2K150890Exactech Optetrak Logic CCExactech, Inc.201534
+2K143242Rebel 3DKNEE SystemEncore Medical L.P.20151117
+2K140830Exprt Revision KneeEncore Medical L.P.201471
+2K132161Optetrak Logic PS 17MM & 19MM Thick Inserts, Optetrak Logic PSC 17MM & 19MM Thick InsertsExactech, Inc.201331
+2K122239Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn Coating…Encore Medical L.P.201320—
+2K123687Optetrak Logic Porous Femoral ComponentExactech, Inc.20137—
+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
+2K111400Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral ComponentExactech, Inc.2011121
+2K110547Optertrak Logic PSC Tibial InsertExactech Sarasota20114—
+2K071738Exactech Optetrak Proximal Tibial SpacerExactech, Inc.200702
+2K033883Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized Cemented Femoral…Exactech, Inc.2004173
+2K030686Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc.200386—
+2K023186Optetrak Total Knee System Offset Tibial TrayExactech, Inc.2002134
+3K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20260—
+3K241180Consensus Knee System with TiNbNShalby Advanced Technologies20251—
+3K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc.202301
+3K213793EMPOWR Revision KneeEncore Medical L.P.20221—
+3K200912Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc.20202—
+3K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+3K182872LINK GEMINI SL Total Knee SystemWaldemar Link GmbH & Co. KG20198—
+3K180930Empowr VVC Tibial InsertEncore Medical L.P.201831
+3K171991EMPOWR Porous Knee SystemEncore Medical L.P.201713
+3K170573Empowr CR Knee Tibial InsertEncore Medical L.P.20170—
+3K171045Exactech® Truliant™ Line ExtensionsExactech, Inc.201712
+3K170240Truliant Femoral ComponentsExactech, Inc.20172—
+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—
+3K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx…Waldemar Link GmbH & Co. KG2016916
+3K140302Optetrak Logic Porous Femoral ComponentsExactech, Inc.20141—
+3K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201333—
+3K123342Optetrak Logic CRC Tibial InsertExactech, Inc.20134—
+3K121307Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial Insert, Size 6 Optetrak…Exactech, Inc.201211—
+3K090411Freedom Metal Backed Tibial ComponentMaxx Orthopedics, Inc.200915—
+4K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.20260—
+4K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.20250—
+4K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+4K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc.20251—
+4K250382Freedom Total Knee System (All-poly Tibial Plate)Maxx Orthopedics, Inc.20251—
+4K230169EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial InsertEncore Medical, L.P Dba Enovis20232—
+4K230441EMPOWR Stem Extender, 50mmEncore Medical, L.P Dba Enovis20230—
+4K220628LINK Endo-Model EVO Knee SystemWaldemar Link GmbH & Co. KG20220—
+4K212839Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd.20211—
+4K212742GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK…Waldemar Link GmbH & Co. KG2021122
+4K211768LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPEWaldemar Link GmbH & Co. KG20210—
+4K202924LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG2021211
+4K201611Apex Knee SystemOmnilife Science20210—
+4K210308EMPOWR Porous Femur with HAnano SurfaceTMEncore Medical L.P.20210—
+4K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+4K191755SPAR-K Instruments (for use with Gemini SL Total Knee System)Waldemar Link GmbH & Co. KG20190—
+4K181794Truliant Porous Femoral ComponentsExactech, Inc.20180—
+4K161414Anatomic Total Knee SystemAmplitude20171—
+4K160771Destiknee Total Knee SystemMeril Healthcare Private Limited20163—
+4K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+4K133560Itotal Cruciate Retaining Knee Replacment SystemConformis, Inc.20140—
+4K131481Freedom PCK ComponentsMaxx Orthopedics, Inc.20146—
+4K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201330—
+4K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.201330—
+4K123692Pipeline Knee SystemPipeline Orthopedics20130—
+5K253144Freedom® Total Knee System – Titan PCK ComponentsMaxx Orthopedics, Inc.20250—
+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—
+5K240863Freedom® Total Knee SystemMaxx Orthopedics, Inc.20240—
+5K230078TRAX® CR Total Knee SystemAmplitude20230—
+5K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+5K222816Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd.20220—
+5K211664GMK Sphere RevisionMedacta International S.A.20210—
+5K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+5K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+5K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+5K172936Destiknee™ Total Knee SystemMeril Healthcare Pvt., Ltd.20172—
+5K150680Freedom Cementless Femoral ComponentMaxx Orthopedics, Inc.20151—
+5K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+5K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2014251
+5K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+6K203421Triathlon AS-1Conformis, Inc.20210—
+6K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+6K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+6K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+6K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+7K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+7K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+7K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+7K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+7K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+7K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201
+7K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+7K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+8K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+8K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+8K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174