510(k) Report

Devices descending from K010170

297 later devices reach Trident Porous Titanium Acetabular Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+6K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+6K122232GMK NarrowMedacta International20128—
+6K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+6K103721Mpact Acetabular SystemMedacta International201121—
+6K103352Versafitcup CC TrioMedacta International20114—
+6K102437GMK Revision Knee SystemMedacta International S.A.201034—
+6K093806Myknee Cutting BlocksMedacta International S.A.201016—
+7K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+7K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+7K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+7K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+7K241461Mpact Constrained LinerMedacta International S.A.20251—
+7K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+7K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+7K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+7K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+7K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+7K230011Mpact ExtensionMedacta International S.A.20233—
+7K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+7K231037MyKnee UNI-STMedacta International S.A.20230—
+7K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+7K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+7K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+7K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+7K200391MPACT ExtensionMedacta International S.A.20210—
+7K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+7K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+7K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+7K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+7K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+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—
+7K183582MPACT ExtensionMedacta International S.A.20194—
+7K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+7K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+7K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+7K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+7K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+7K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+7K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+7K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+7K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+7K171249Entrada™ hip stemOrtho Development Corporation20172—
+7K171156OMNI Anseris Hip StemOmnilife Science20170—
+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
+7K132879Mpact ExtensionMedacta International201411—
+7K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+7K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+7K122911Versafitcup CC Trio ExtensionMedacta International20121—
+7K122641Mpact ExtensionMedacta International201214—
+7K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+7K111145Endo HeadMedacta International20110—
+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—
+8K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+8K252847NextAR Hip PlatformMedacta International S.A.20260—
+8K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+8K251166Mfinity Femoral SystemMedacta International S.A.20250—
+8K251052Trivicta® Hip StemOrtho Development Corp.20250—
+8K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+8K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+8K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+8K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+8K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+8K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+8K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+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—
+8K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+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—
+9K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+9K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+10K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+10K233172NextAR™ Spine PlatformMedacta International S.A.20241—