510(k) Report

Devices descending from K810258

509 later devices reach Proximal Fermoral Hip Replacement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+10K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+10K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+10K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+10K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+10K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+10K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+10K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+10K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+10K230169EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial InsertEncore Medical, L.P Dba Enovis20232—
+10K230441EMPOWR Stem Extender, 50mmEncore Medical, L.P Dba Enovis20230—
+10K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+10K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+10K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+10K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+10K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+10K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+10K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+10K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+10K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+10K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+10K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+10K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+10K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+10K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+10K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+10K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+10K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+10K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+10K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+10K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+10K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+10K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+10K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+10K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201
+10K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+10K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+10K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+10K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+10K130634Corin Metafix Hip StemCorin USA20135—
+10K121563Corin Trifit TS HipCorin USA2012101
+10K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+10K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+10K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+10K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+11K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+11K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+11K250644MSS - Monobloc stemMedacta International S.A.202611
+11K254003JARVIS Metaphyseal StemFH Industrie20260—
+11K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+11K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+11K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)Encore Medical L.P.20250—
+11K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P.20250—
+11K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+11K243248Inhance Intact™Depuy Ireland UC20240—
+11K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+11K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+11K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+11K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+11K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+11K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+11K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+11K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+11K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+11K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+11K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+11K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+11K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+11K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+11K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+11K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+11K171249Entrada™ hip stemOrtho Development Corporation20172—
+11K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+11K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174
+11K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+11K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+11K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+11K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+11K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+11K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+12K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+12K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+12K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+12K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+12K251166Mfinity Femoral SystemMedacta International S.A.20250—
+12K251052Trivicta® Hip StemOrtho Development Corp.20250—
+12K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+12K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+12K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+12K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+12K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+12K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+12K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+12K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+12K211703Insignia Hip StemStryker Orthopaedics20217—
+12K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+12K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+12K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+12K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+12K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—