510(k) Report

Devices descending from K050327

289 later devices reach E-Poly (Vitamin E) Acetabular Liners through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+6K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+6K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+6K230078TRAX® CR Total Knee SystemAmplitude20230—
+6K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+6K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+6K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+6K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+6K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+6K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+6K213793EMPOWR Revision KneeEncore Medical L.P.20221—
+6K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+6K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+6K203421Triathlon AS-1Conformis, Inc.20210—
+6K210308EMPOWR Porous Femur with HAnano SurfaceTMEncore Medical L.P.20210—
+6K210551Persona Revision Knee SystemZimmer, Inc.202101
+6K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+6K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+6K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+6K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+6K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+6K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+6K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+6K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190—
+6K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+6K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+6K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+6K180930Empowr VVC Tibial InsertEncore Medical L.P.201831
+6K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+6K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+6K161945EXPRT Revision Knee Femoral Augment (5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.20160—
+6K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+6K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+7K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+7K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+7K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+7K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+7K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+7K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+7K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+7K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+7K230169EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial InsertEncore Medical, L.P Dba Enovis20232—
+7K230441EMPOWR Stem Extender, 50mmEncore Medical, L.P Dba Enovis20230—
+7K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+7K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+7K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+7K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+7K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+7K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+7K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+7K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+7K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+7K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+7K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+7K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+7K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+7K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+7K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+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—
+8K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+8K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+8K250644MSS - Monobloc stemMedacta International S.A.202611
+8K254003JARVIS Metaphyseal StemFH Industrie20260—
+8K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+8K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+8K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)Encore Medical L.P.20250—
+8K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P.20250—
+8K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+8K243248Inhance Intact™Depuy Ireland UC20240—
+8K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+8K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+8K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+8K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+8K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+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
+9K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+9K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+9K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+9K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+9K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+9K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+10K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+11K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301