510(k) Report

Devices descending from K091956

119 later devices reach Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143242Rebel 3DKNEE SystemEncore Medical L.P.20151117
+1K131337Balanced Knee System High Flex Vitamin E PS Tibial Insert and PatellaOrtho Development Corp.20133—
+1K130365X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P.201338—
+1K123982Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+Encore Medical L.P.201335—
+1K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201333—
+1K121727Movation Knee SystemEncore Medical L.P.201214—
+1K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+1K113756Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly…Encore Medical L.P.2012351
+1K103223Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P.201037—
+2K233093Balanced Knee® System TriMax PS Plus Tibial InsertOrtho Development Corporation20230—
+2K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+2K190057DJO Acetabular SystemEncore Medical L.P.201925
+2K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+2K173723EMPOWR Universal Tibial BaseplateEncore Medical L.P.201821
+2K172651FMP Extended LinersEncore Medical L.P.20173—
+2K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+2K171991EMPOWR Porous Knee SystemEncore Medical L.P.201713
+2K170573Empowr CR Knee Tibial InsertEncore Medical L.P.20170—
+2K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+2K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+2K160342EMPOWR PS Knee SystemEncore Medical L.P.201665
+2K152169Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial InsertsOrtho Development Corporation20151—
+2K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+2K140130X-Alt Highly Cross Linked Acetabular Liners with Vitamin E, Neutral, 10 Degree Hooded…Encore Medical L.P.20141—
+2K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+2K140830Exprt Revision KneeEncore Medical L.P.201471
+2K141006RSP Humeral Socket InsertDjo Global2014212
+2K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+2K133560Itotal Cruciate Retaining Knee Replacment SystemConformis, Inc.20140—
+2K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201330—
+2K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.201330—
+2K123692Pipeline Knee SystemPipeline Orthopedics20130—
+2K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132—
+2K121835Domed Tri-Peg Patella, Highly Cross Linked Domed Tri-Peg Patella with VEEncore Medical L.P.20120—
+3K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.20250—
+3K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+3K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+3K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+3K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+3K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+3K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+3K213793EMPOWR Revision KneeEncore Medical L.P.20221—
+3K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+3K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+3K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+3K210308EMPOWR Porous Femur with HAnano SurfaceTMEncore Medical L.P.20210—
+3K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+3K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+3K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+3K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+3K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+3K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+3K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+3K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K180930Empowr VVC Tibial InsertEncore Medical L.P.201831
+3K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+3K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+3K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+3K161945EXPRT Revision Knee Femoral Augment (5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.20160—
+3K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+3K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2014251
+3K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+4K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+4K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+4K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+4K230169EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial InsertEncore Medical, L.P Dba Enovis20232—
+4K230441EMPOWR Stem Extender, 50mmEncore Medical, L.P Dba Enovis20230—
+4K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+4K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+4K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+4K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+4K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+4K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+4K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+4K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+4K203421Triathlon AS-1Conformis, Inc.20210—
+4K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+4K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+4K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+4K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+4K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+5K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+5K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+5K250644MSS - Monobloc stemMedacta International S.A.202611
+5K254003JARVIS Metaphyseal StemFH Industrie20260—
+5K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+5K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+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—
+5K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+5K243248Inhance Intact™Depuy Ireland UC20240—
+5K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+5K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+5K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+5K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+5K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+5K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+5K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—