510(k) Report

Devices descending from K001277

213 later devices reach Triflange Acetabular Cup System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K231178ACTERA™ hip systemConformis, Inc.20230—
+5K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+5K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+5K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+5K200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.20200—
+5K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+5K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+5K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+5K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+5K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+5K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+5K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+5K142069GMK ExtensionMedacta International20144—
+5K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+5K131986Corin Minihip StemCorin USA20133—
+5K131310GMK Full PE Tibial ComponentsMedacta International20132—
+5K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+5K121416GMK SphereMedacta International201220—
+5K120790GMK - Line ExtensionMedacta International201211—
+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—
+5K103518Trinity Acetabular SystemCorin USA20118—
+5K090988GMK Total Knee SystemMedacta International S.A.2009521
+5K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+6K262057GMK ExtensionMedacta International SA20260—
+6K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+6K250450Coated hip implantsMedacta International S.A.20250—
+6K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+6K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+6K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+6K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+6K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+6K211664GMK Sphere RevisionMedacta International S.A.20210—
+6K211866Bencox THR SystemCorentec Co., Ltd.20210—
+6K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+6K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+6K210062Mectaplug PE IIMedacta International S.A.20210—
+6K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+6K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+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—
+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—
+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—
+7K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+7K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+7K230011Mpact ExtensionMedacta International S.A.20233—
+7K231037MyKnee UNI-STMedacta International S.A.20230—
+7K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+7K200391MPACT ExtensionMedacta International S.A.20210—
+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—
+7K183582MPACT ExtensionMedacta International S.A.20194—
+7K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+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—
+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—
+7K143453Mpact Double Mobility SystemMedacta International20151—
+7K132879Mpact ExtensionMedacta International201411—
+7K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+7K131458Mpact DM Liner ConverterMedacta International20133—
+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—
+8K252847NextAR Hip PlatformMedacta International S.A.20260—
+8K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+8K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+8K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+8K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—