510(k) Report

Devices descending from K000760

238 later devices reach Reach Femoral Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+4K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp.20143—
+4K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+4K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+4K123550Utf Stem, ReducedUnited Orthopedic Corporation20134—
+4K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212—
+4K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123—
+4K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc.20120—
+4K122099Bencox II Stem, Bencox Metal HeadCorentec Co., Ltd.20120—
+4K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+4K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122—
+4K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.201220—
+4K121263Taper Set Hip System RDP StemConsensus Orthopedics, Inc.20120—
+4K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc.20120—
+4K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.201213—
+4K112802Pipeline Total Hip SystemPipeline Orthopedics201253—
+4K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114—
+4K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+4K093235Ringloc + Hybrid Acetabular SystemBiomet, Inc.20106530
+4K083642Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc.20090—
+5K261453G7® Acetabular SystemZimmer Biomet20260—
+5K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+5K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+5K252067Velora Acetabular SystemRestor3D, Inc.20250—
+5K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+5K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+5K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+5K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+5K243809Biolox® Delta Revision headsLimacorporate20250—
+5K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+5K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+5K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+5K230011Mpact ExtensionMedacta International S.A.20233—
+5K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+5K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+5K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+5K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+5K211866Bencox THR SystemCorentec Co., Ltd.20210—
+5K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+5K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+5K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+5K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+5K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+5K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+5K191816M-Vizion Femoral Revision System ExtensionMedacta International S.A.20204—
+5K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+5K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+5K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+5K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+5K182099Delta TT ProLima Corporate S.P.A.20183—
+5K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+5K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+5K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+5K170690M-Vizion Femoral Revision SystemMedacta International S.A.20175—
+5K170473C2 femoral stemLima Corporate S.P.A.20170—
+5K171249Entrada™ hip stemOrtho Development Corporation20172—
+5K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+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—
+5K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+5K160011H-Max S stemLima Corporate S.P.A.20161—
+5K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+5K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+5K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+5K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+5K141395Delta TT Acetabular SystemLima Corporate S.P.A.2014101
+5K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+5K132207Utf Stem-Reduced, Additional SizesUnited Orthopedic Corporation20133—
+5K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+5K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+5K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+5K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+6K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+6K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+6K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+6K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+6K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+6K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+6K250450Coated hip implantsMedacta International S.A.20250—
+6K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+6K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+6K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+6K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+6K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+6K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+6K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+6K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+6K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+6K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+6K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+6K212327M-Vizion MonoblocMedacta International S.A.20221—
+6K201471M-Vizion Femoral Revision System ExtensionMedacta International S.A.20213—
+6K202484Cordera Hip SystemConformis, Inc.202022
+6K192198Conformis Hip SystemConformis, Inc.2019121
+6K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+6K190904Conformis BeneFIT Hip SystemConformis, Inc.201961