510(k) Report

Devices descending from K000306

403 later devices reach Pinnacle Acetabular System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K113571GMK Resufacing Patella Size 4Medacta International201223—
+5K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+5K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+5K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+5K111283GMK Revision Hybrid LinersMedacta International20110—
+5K090988GMK Total Knee SystemMedacta International S.A.2009521
+5K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+6K262057GMK ExtensionMedacta International SA20260—
+6K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+6K231178ACTERA™ hip systemConformis, Inc.20230—
+6K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+6K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+6K221104Actera™ hip systemConformis, Inc.202211
+6K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+6K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+6K211664GMK Sphere RevisionMedacta International S.A.20210—
+6K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+6K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+6K210062Mectaplug PE IIMedacta International S.A.20210—
+6K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+6K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+6K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+6K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+6K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+6K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+6K162035GMK SphereMedacta International S.A.201710—
+6K140826GMK Sphere ExtensionMedacta International201417—
+6K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+6K133630GMK Short StemMedacta International20131—
+6K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+6K123721GMK Revision ExtensionMedacta International20133—
+6K130634Corin Metafix Hip StemCorin USA20135—
+6K122232GMK NarrowMedacta International20128—
+6K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+6K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+6K103352Versafitcup CC TrioMedacta International20114—
+6K102437GMK Revision Knee SystemMedacta International S.A.201034—
+6K093806Myknee Cutting BlocksMedacta International S.A.201016—
+7K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+7K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+7K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+7K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+7K231037MyKnee UNI-STMedacta International S.A.20230—
+7K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+7K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+7K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+7K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+7K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+7K193559NextAR TKA PlatformMedacta Inernational SA202012—
+7K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+7K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+7K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+7K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+7K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+7K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+7K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+7K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+7K171249Entrada™ hip stemOrtho Development Corporation20172—
+7K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+7K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+7K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+7K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+8K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+8K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+8K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+8K252847NextAR Hip PlatformMedacta International S.A.20260—
+8K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+8K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+8K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+8K251166Mfinity Femoral SystemMedacta International S.A.20250—
+8K251052Trivicta® Hip StemOrtho Development Corp.20250—
+8K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+8K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+8K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+8K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+8K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+8K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+8K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+8K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+8K220705MyKnee R Pin PositionersMedacta International S.A.20220—
+8K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+8K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+8K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+8K211703Insignia Hip StemStryker Orthopaedics20217—
+8K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+8K210153NextAR RSA PlatformMedacta International S.A.202151
+8K202152NextAR TKA PlatformMedacta International S.A.202011—
+8K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+8K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+8K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+9K250477NextAR (TM) SpineMedacta International S.A.20250—
+9K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+9K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+9K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+9K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+9K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+9K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+10K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+10K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+10K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—