510(k) Report

Devices descending from K993768

224 later devices reach Citation TMZF HA Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+5K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+5K212327M-Vizion MonoblocMedacta International S.A.20221—
+5K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+5K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+5K211866Bencox THR SystemCorentec Co., Ltd.20210—
+5K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+5K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+5K191816M-Vizion Femoral Revision System ExtensionMedacta International S.A.20204—
+5K191358Trident II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20196—
+5K192352MiniMAXMedacta International S.A.20192—
+5K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+5K191781Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis SystemZimmer GmbH20191—
+5K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+5K181693SMS Femoral StemMedacta International S.A.20184—
+5K170690M-Vizion Femoral Revision SystemMedacta International S.A.20175—
+5K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+5K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+5K163497EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal…Encore Medical L.P.201701
+5K161226Revision Femoral StemLima Corporate S.P.A.20170—
+5K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+5K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH20168—
+5K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+5K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+5K150062Excia Total Hip SystemAesculap Implant Systems, LLC20151—
+5K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+5K141327Minima S SystemLima Corporate S.P.A.20145—
+5K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+5K131986Corin Minihip StemCorin USA20133—
+5K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+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—
+5K103518Trinity Acetabular SystemCorin USA20118—
+6K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+6K231925MINIMA S SystemLima Corporate S.P.A.20230—
+6K220376Acetabular Dome Hole PlugHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+6K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+6K201471M-Vizion Femoral Revision System ExtensionMedacta International S.A.20213—
+6K203041SMS Cementless StemMedacta International S.A.20201—
+6K201673SMS Cementless StemMedacta International S.A.20203—
+6K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+6K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+6K170473C2 femoral stemLima Corporate S.P.A.20170—
+6K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+6K160011H-Max S stemLima Corporate S.P.A.20161—
+6K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+6K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+6K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+6K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+6K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+7K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+7K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+7K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+7K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+7K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+7K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+7K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+7K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+7K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+7K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+7K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+7K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+7K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+7K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+7K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+7K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+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—
+7K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+7K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+7K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+8K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+8K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+8K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+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—
+8K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+8K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+8K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+8K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+8K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+8K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+8K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+8K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+8K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+8K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+8K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+8K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+8K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+8K163577Ecofit® Hip SystemImplantcast GmbH201791