510(k) Report

Devices descending from K983014

404 later devices reach Summit Acetabular System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+6K113571GMK Resufacing Patella Size 4Medacta International201223—
+6K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+6K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+6K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+6K111283GMK Revision Hybrid LinersMedacta International20110—
+6K090988GMK Total Knee SystemMedacta International S.A.2009521
+6K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+7K262057GMK ExtensionMedacta International SA20260—
+7K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+7K231178ACTERA™ hip systemConformis, Inc.20230—
+7K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+7K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+7K221104Actera™ hip systemConformis, Inc.202211
+7K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+7K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+7K211664GMK Sphere RevisionMedacta International S.A.20210—
+7K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+7K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+7K210062Mectaplug PE IIMedacta International S.A.20210—
+7K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+7K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+7K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+7K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+7K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+7K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+7K162035GMK SphereMedacta International S.A.201710—
+7K140826GMK Sphere ExtensionMedacta International201417—
+7K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+7K133630GMK Short StemMedacta International20131—
+7K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+7K123721GMK Revision ExtensionMedacta International20133—
+7K130634Corin Metafix Hip StemCorin USA20135—
+7K122232GMK NarrowMedacta International20128—
+7K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+7K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+7K103352Versafitcup CC TrioMedacta International20114—
+7K102437GMK Revision Knee SystemMedacta International S.A.201034—
+7K093806Myknee Cutting BlocksMedacta International S.A.201016—
+8K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+8K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+8K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+8K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+8K231037MyKnee UNI-STMedacta International S.A.20230—
+8K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+8K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+8K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+8K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+8K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+8K193559NextAR TKA PlatformMedacta Inernational SA202012—
+8K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+8K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+8K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+8K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+8K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+8K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+8K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+8K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+8K171249Entrada™ hip stemOrtho Development Corporation20172—
+8K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+8K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+8K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+8K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+9K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+9K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+9K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+9K252847NextAR Hip PlatformMedacta International S.A.20260—
+9K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+9K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+9K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+9K251166Mfinity Femoral SystemMedacta International S.A.20250—
+9K251052Trivicta® Hip StemOrtho Development Corp.20250—
+9K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+9K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+9K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+9K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+9K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+9K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+9K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+9K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+9K220705MyKnee R Pin PositionersMedacta International S.A.20220—
+9K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+9K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+9K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+9K211703Insignia Hip StemStryker Orthopaedics20217—
+9K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+9K210153NextAR RSA PlatformMedacta International S.A.202151
+9K202152NextAR TKA PlatformMedacta International S.A.202011—
+9K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+9K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+9K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+10K250477NextAR (TM) SpineMedacta International S.A.20250—
+10K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+10K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+10K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+10K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+10K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+10K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+11K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+11K233172NextAR™ Spine PlatformMedacta International S.A.20241—