510(k) Report

Devices descending from K810520

87 later devices reach Insall/Burstein Constrained Total Condyl through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030686Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc.200386—
+2K100900Motivation Knee SystemEncore Medical L.P.2010724
+2K090411Freedom Metal Backed Tibial ComponentMaxx Orthopedics, Inc.200915—
+3K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.20260—
+3K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.20250—
+3K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc.20251—
+3K250382Freedom Total Knee System (All-poly Tibial Plate)Maxx Orthopedics, Inc.20251—
+3K200912Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc.20202—
+3K173723EMPOWR Universal Tibial BaseplateEncore Medical L.P.201821
+3K161414Anatomic Total Knee SystemAmplitude20171—
+3K160771Destiknee Total Knee SystemMeril Healthcare Private Limited20163—
+3K160342EMPOWR PS Knee SystemEncore Medical L.P.201665
+3K143242Rebel 3DKNEE SystemEncore Medical L.P.20151117
+3K140830Exprt Revision KneeEncore Medical L.P.201471
+3K131481Freedom PCK ComponentsMaxx Orthopedics, Inc.20146—
+3K122239Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn Coating…Encore Medical L.P.201320—
+3K121727Movation Knee SystemEncore Medical L.P.201214—
+3K121835Domed Tri-Peg Patella, Highly Cross Linked Domed Tri-Peg Patella with VEEncore Medical L.P.20120—
+3K113756Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly…Encore Medical L.P.2012351
+4K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20260—
+4K253144Freedom® Total Knee System – Titan PCK ComponentsMaxx Orthopedics, Inc.20250—
+4K241180Consensus Knee System with TiNbNShalby Advanced Technologies20251—
+4K240863Freedom® Total Knee SystemMaxx Orthopedics, Inc.20240—
+4K230078TRAX® CR Total Knee SystemAmplitude20230—
+4K213793EMPOWR Revision KneeEncore Medical L.P.20221—
+4K212839Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd.20211—
+4K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+4K182872LINK GEMINI SL Total Knee SystemWaldemar Link GmbH & Co. KG20198—
+4K180930Empowr VVC Tibial InsertEncore Medical L.P.201831
+4K172936Destiknee™ Total Knee SystemMeril Healthcare Pvt., Ltd.20172—
+4K171991EMPOWR Porous Knee SystemEncore Medical L.P.201713
+4K170573Empowr CR Knee Tibial InsertEncore Medical L.P.20170—
+4K161945EXPRT Revision Knee Femoral Augment (5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.20160—
+4K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx…Waldemar Link GmbH & Co. KG2016916
+4K150680Freedom Cementless Femoral ComponentMaxx Orthopedics, Inc.20151—
+4K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201333—
+5K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+5K230169EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial InsertEncore Medical, L.P Dba Enovis20232—
+5K230441EMPOWR Stem Extender, 50mmEncore Medical, L.P Dba Enovis20230—
+5K222816Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd.20220—
+5K220628LINK Endo-Model EVO Knee SystemWaldemar Link GmbH & Co. KG20220—
+5K212742GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK…Waldemar Link GmbH & Co. KG2021122
+5K211768LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPEWaldemar Link GmbH & Co. KG20210—
+5K202924LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG2021211
+5K201611Apex Knee SystemOmnilife Science20210—
+5K210308EMPOWR Porous Femur with HAnano SurfaceTMEncore Medical L.P.20210—
+5K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+5K191755SPAR-K Instruments (for use with Gemini SL Total Knee System)Waldemar Link GmbH & Co. KG20190—
+5K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+5K133560Itotal Cruciate Retaining Knee Replacment SystemConformis, Inc.20140—
+5K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201330—
+5K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.201330—
+5K123692Pipeline Knee SystemPipeline Orthopedics20130—
+6K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)Encore Medical L.P.20250—
+6K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P.20250—
+6K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+6K211664GMK Sphere RevisionMedacta International S.A.20210—
+6K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+6K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+6K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+6K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+6K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2014251
+6K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+7K203421Triathlon AS-1Conformis, Inc.20210—
+7K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+7K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+7K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+7K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+8K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+8K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+8K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+8K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+8K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+8K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201
+8K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+8K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+9K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+9K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+9K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174
+10K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+10K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+10K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+11K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+11K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+11K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+12K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+12K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301