510(k) Report

Devices descending from K000788

168 later devices reach Apex Modular Hip Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241472Icona Hip StemCorin U.S.A. Limited20241—
+1K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+1K171156OMNI Anseris Hip StemOmnilife Science20170—
+1K101575Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810…Omnlife Science201024—
+1K100555Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKOmni Life Science, Inc.2010341
+1K043123Apex Modular HA Hip StemApex Surgical, LLC2005131—
+1K041950Apex K2 Hip SystemApex Surgical, LLC2004621
+1K041850Medallion Modular Hip SystemBiomet Manufacturing, Inc.20041—
+2K261576Icona Hip StemCorin, Ltd.20260—
+2K152919OMNI Skirted HeadsOmni Life Science, Inc.20161—
+2K142675CI../..X liner for NOVAE Dual Mobility Acetabular CupSerf20153—
+2K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+2K103721Mpact Acetabular SystemMedacta International201121—
+2K101976Interface Acetabular System, Acetabular Insert +4 OffsetOmni Life Science, Inc.201011
+2K101451Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc.20104—
+2K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+2K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+2K080842Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc.200861—
+2K060072Monoblock Press-Fit Hip StemOmni Life Science, Inc.200671
+3K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+3K250450Coated hip implantsMedacta International S.A.20250—
+3K241461Mpact Constrained LinerMedacta International S.A.20251—
+3K230011Mpact ExtensionMedacta International S.A.20233—
+3K220495SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20231—
+3K211742SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20222—
+3K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+3K200391MPACT ExtensionMedacta International S.A.20210—
+3K183582MPACT ExtensionMedacta International S.A.20194—
+3K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+3K143453Mpact Double Mobility SystemMedacta International20151—
+3K132879Mpact ExtensionMedacta International201411—
+3K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+3K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+3K131458Mpact DM Liner ConverterMedacta International20133—
+3K122911Versafitcup CC Trio ExtensionMedacta International20121—
+3K122641Mpact ExtensionMedacta International201214—
+3K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+3K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+3K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+3K111145Endo HeadMedacta International20110—
+3K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+3K110947Apex K1 Hip StemOmni Life Science, Inc.20116—
+3K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+3K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+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—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+4K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+4K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+4K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+4K211891DM Converter - TiN coatedMedacta International S.A.20220—
+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—
+4K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+4K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+4K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+4K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+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—
+5K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+5K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+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—
+5K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+5K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+5K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+5K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+5K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+5K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+5K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+5K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+5K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+5K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+5K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+5K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+5K171249Entrada™ hip stemOrtho Development Corporation20172—
+5K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+5K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+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
+6K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+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