510(k) Report

Devices descending from K962007

225 later devices reach Protrusion Cages through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K120924Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw…Corentec Co., Ltd.20128—
+5K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+5K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+5K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+5K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+5K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+5K083312Minihip StemCorin USA201015—
+5K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+5K081023Evolis Total Knee SystemMedacta International S.A.2008781
+5K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc.20082—
+6K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+6K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+6K231178ACTERA™ hip systemConformis, Inc.20230—
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+6K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+6K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+6K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+6K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+6K200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.20200—
+6K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+6K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+6K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+6K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+6K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+6K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+6K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+6K142069GMK ExtensionMedacta International20144—
+6K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+6K131986Corin Minihip StemCorin USA20133—
+6K131310GMK Full PE Tibial ComponentsMedacta International20132—
+6K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+6K121416GMK SphereMedacta International201220—
+6K120790GMK - Line ExtensionMedacta International201211—
+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—
+6K103518Trinity Acetabular SystemCorin USA20118—
+6K090988GMK Total Knee SystemMedacta International S.A.2009521
+6K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+7K262057GMK ExtensionMedacta International SA20260—
+7K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+7K250450Coated hip implantsMedacta International S.A.20250—
+7K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+7K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+7K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+7K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+7K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+7K211664GMK Sphere RevisionMedacta International S.A.20210—
+7K211866Bencox THR SystemCorentec Co., Ltd.20210—
+7K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+7K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+7K210062Mectaplug PE IIMedacta International S.A.20210—
+7K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+7K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+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—
+7K122232GMK NarrowMedacta International20128—
+7K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+7K103721Mpact Acetabular SystemMedacta International201121—
+7K103352Versafitcup CC TrioMedacta International20114—
+7K102437GMK Revision Knee SystemMedacta International S.A.201034—
+7K093806Myknee Cutting BlocksMedacta International S.A.201016—
+8K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+8K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+8K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+8K241461Mpact Constrained LinerMedacta International S.A.20251—
+8K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+8K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+8K230011Mpact ExtensionMedacta International S.A.20233—
+8K231037MyKnee UNI-STMedacta International S.A.20230—
+8K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+8K200391MPACT ExtensionMedacta International S.A.20210—
+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—
+8K183582MPACT ExtensionMedacta International S.A.20194—
+8K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+8K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+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—
+8K171156OMNI Anseris Hip StemOmnilife Science20170—
+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—
+8K143453Mpact Double Mobility SystemMedacta International20151—
+8K132879Mpact ExtensionMedacta International201411—
+8K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—