510(k) Report

Devices descending from K921308

472 later devices reach HG Multilock Hip Prosthesis W/ TI-Nidium through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K140915Excia Total Hip SystemAesculap Implant Systems, LLC20142—
+5K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp.20143—
+5K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+5K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+5K131354Renovis Bipolar Hip SystemRenovis Surgical Technologies, LLC20131—
+5K131884Avenir Cemented Hip StemZimmer GmbH20131—
+5K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+5K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+5K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+5K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+5K121627Smith & Nephew Redapt Revision Femoral SystemSmith & Nephew, Inc.201251
+5K120595Unisyn Plus Hip StemConsensus Orthopedics, Inc.20120—
+5K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+5K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122—
+5K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+5K120030Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp201214—
+5K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.201213—
+5K113789Modular Proximally Fluted Hip StemSmith & Nephew, Inc.201281
+5K113556Wagner Cone Prosthesis SystemZimmer GmbH201291
+5K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+5K103431Coren Total Hip SystemCorentec Co., Ltd.201111—
+5K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+5K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122—
+5K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+5K103256Smith & Nephew SMF Hip StemSmith & Nephew, Inc.2011162
+5K093472Trinity Acetabular SystemCorin USA20101171
+5K100481Smith & Nephew MDF Modular SleeveSmith & Nephew, Inc.20105—
+5K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc.20093—
+5K081023Evolis Total Knee SystemMedacta International S.A.2008781
+5K071583Cermet Iii Acetabular Cup SystemImplants International, Ltd.20070—
+5K062684Excia Total Hip System 36MM Ceramic HeadAesculap, Inc.200665—
+5K060437Excia Total Hip System with U-CapAesculap, Inc.200690—
+6K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+6K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.20260—
+6K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+6K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+6K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+6K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+6K243809Biolox® Delta Revision headsLimacorporate20250—
+6K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+6K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+6K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+6K241241Z1 Cemented Hip SystemOrchard Medical Development, LLC20240—
+6K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+6K233476Z1 Hip SystemOrchard Medical Development202421
+6K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+6K231178ACTERA™ hip systemConformis, Inc.20230—
+6K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+6K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+6K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+6K212327M-Vizion MonoblocMedacta International S.A.20221—
+6K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+6K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+6K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+6K211866Bencox THR SystemCorentec Co., Ltd.20210—
+6K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+6K191816M-Vizion Femoral Revision System ExtensionMedacta International S.A.20204—
+6K200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.20200—
+6K192189Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc.20194—
+6K191358Trident II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20196—
+6K192352MiniMAXMedacta International S.A.20192—
+6K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+6K191781Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis SystemZimmer GmbH20191—
+6K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+6K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+6K182462Exactech Alteon Highly Polished Femoral StemExactech, Inc.20180—
+6K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+6K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+6K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+6K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+6K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189—
+6K180334LEGION Knee SystemSmith & Nephew, Inc.20184—
+6K171273LINK® BiMobile (TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG201842
+6K170690M-Vizion Femoral Revision SystemMedacta International S.A.20175—
+6K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+6K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+6K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+6K171249Entrada™ hip stemOrtho Development Corporation20172—
+6K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+6K163497EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal…Encore Medical L.P.201701
+6K161226Revision Femoral StemLima Corporate S.P.A.20170—
+6K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+6K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH20168—
+6K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+6K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+6K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+6K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+6K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+6K151902REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc.20157—
+6K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+6K142761Corin TaperFit Hip StemCorin USA201541
+6K150503Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc.20150—
+6K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+6K142069GMK ExtensionMedacta International20144—
+6K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+6K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+6K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+6K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+6K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—