510(k) Report

Devices descending from K021403

132 later devices reach HA Mallory/Head Porous Femoral Stem & HA Mallory/Head Porous Lateralized… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043123Apex Modular HA Hip StemApex Surgical, LLC2005131—
+2K171156OMNI Anseris Hip StemOmnilife Science20170—
+2K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+2K080842Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc.200861—
+3K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+3K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+3K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+3K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+3K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+3K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+3K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+3K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+4K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+4K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+4K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+4K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+4K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+4K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+4K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+4K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+4K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+4K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+4K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+4K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+5K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+5K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+5K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+5K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+5K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+5K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+5K240876Identity Shoulder SystemZimmer, Inc.20241—
+5K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+5K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+5K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+5K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+5K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+5K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+5K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+5K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+5K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+5K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+5K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+5K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+5K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+6K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+6K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+6K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+6K250644MSS - Monobloc stemMedacta International S.A.202611
+6K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+6K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K241043Augment Off-Axis Instrument SystemFix Surgical202415
+6K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+6K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+6K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+6K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+6K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+6K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+6K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+6K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+6K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+6K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+6K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+6K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+6K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+6K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+6K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+6K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+6K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+6K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+6K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+6K171249Entrada™ hip stemOrtho Development Corporation20172—
+6K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+6K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+7K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+7K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+7K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+7K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+7K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+7K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+7K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+7K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+7K251166Mfinity Femoral SystemMedacta International S.A.20250—
+7K251052Trivicta® Hip StemOrtho Development Corp.20250—
+7K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+7K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+7K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+7K241472Icona Hip StemCorin U.S.A. Limited20241—
+7K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+7K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+7K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+7K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+7K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+7K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+7K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+7K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+7K211703Insignia Hip StemStryker Orthopaedics20217—
+7K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+7K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+7K201315PERFORM Humeral System – StemTornier, Inc.2020111
+7K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—