510(k) Report

Devices descending from K915132

315 later devices reach MCK Maximum Congruent Knee) Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+6K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+6K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+6K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+6K200151Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial…Zimmer, Inc.20200—
+6K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+6K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+6K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+6K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+6K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+6K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+6K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+6K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+6K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+6K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+6K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+6K180930Empowr VVC Tibial InsertEncore Medical L.P.201831
+6K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+6K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+6K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+6K163332Apex Revision Knee SystemOmnilife Science20173—
+6K161945EXPRT Revision Knee Femoral Augment (5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.20160—
+6K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20161—
+6K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+6K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+6K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+7K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+7K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+7K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc.20260—
+7K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.20250—
+7K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+7K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+7K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+7K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+7K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+7K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+7K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+7K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+7K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+7K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+7K230078TRAX® CR Total Knee SystemAmplitude20230—
+7K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+7K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+7K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+7K230169EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial InsertEncore Medical, L.P Dba Enovis20232—
+7K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+7K230441EMPOWR Stem Extender, 50mmEncore Medical, L.P Dba Enovis20230—
+7K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+7K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+7K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+7K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+7K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+7K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+7K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+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—
+7K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+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—
+7K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+7K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+7K191831MobiliT CupCorin U.S.A. Limited20203—
+7K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+7K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190—
+7K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+7K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+7K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+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—
+8K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+8K250644MSS - Monobloc stemMedacta International S.A.202611
+8K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+8K254003JARVIS Metaphyseal StemFH Industrie20260—
+8K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+8K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+8K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+8K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+8K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+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—
+8K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+8K241472Icona Hip StemCorin U.S.A. Limited20241—
+8K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+8K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+8K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+8K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+8K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+8K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+8K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—