510(k) Report

Devices descending from K003429

144 later devices reach Malloy/Head Lateralized Press-Fit Femoral through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112019Bencox ID Stem, Bencox Metal Head, Bencox Bipolar CupCorentec Co., Ltd.201110—
+1K021403HA Mallory/Head Porous Femoral Stem & HA Mallory/Head Porous Lateralized Femoral StemBiomet Orthopedics, Inc.2002132—
+2K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+2K122099Bencox II Stem, Bencox Metal HeadCorentec Co., Ltd.20120—
+2K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+2K043123Apex Modular HA Hip StemApex Surgical, LLC2005131—
+3K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+3K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+3K171156OMNI Anseris Hip StemOmnilife Science20170—
+3K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+3K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+3K080842Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc.200861—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+4K211866Bencox THR SystemCorentec Co., Ltd.20210—
+4K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+4K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+4K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+4K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+4K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+4K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+4K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+4K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+4K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+5K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+5K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+5K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+5K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+5K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+5K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+5K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+5K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+5K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+5K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+5K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+5K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+6K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+6K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+6K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+6K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+6K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+6K240876Identity Shoulder SystemZimmer, Inc.20241—
+6K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+6K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+6K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+6K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+6K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+6K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+6K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+6K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+6K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+6K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+6K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+6K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+6K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+7K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+7K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+7K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+7K250644MSS - Monobloc stemMedacta International S.A.202611
+7K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+7K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+7K241043Augment Off-Axis Instrument SystemFix Surgical202415
+7K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+7K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+7K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+7K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+7K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+7K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+7K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+7K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+7K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+7K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+7K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+7K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+7K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+7K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+7K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+7K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+7K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+7K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+7K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+7K171249Entrada™ hip stemOrtho Development Corporation20172—
+7K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+7K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+8K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+8K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+8K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+8K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+8K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+8K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+8K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.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—
+8K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+8K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+8K241472Icona Hip StemCorin U.S.A. Limited20241—
+8K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411