510(k) Report

Devices descending from K951000

405 later devices reach ZTT I and II Acetabular Cup of the S-Rom Total Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+5K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+5K171273LINK® BiMobile (TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG201842
+5K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+5K163577Ecofit® Hip SystemImplantcast GmbH201791
+5K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+5K170444PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc.201716—
+5K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc.20166—
+5K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+5K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20161—
+5K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20160—
+5K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+5K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+5K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+5K142761Corin TaperFit Hip StemCorin USA201541
+5K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+5K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+5K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+5K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+5K141395Delta TT Acetabular SystemLima Corporate S.P.A.2014101
+5K141043CS2 Multi-Hole Acetabular ShellConsensus Orthopedics, Inc.201421—
+5K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+5K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+5K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+5K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+5K131647Trinity Acetabular SystemCorin USA201322—
+5K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+5K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+5K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+5K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+5K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+5K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+5K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123—
+5K121563Corin Trifit TS HipCorin USA2012101
+5K113848R3 Xlpe LinersSmith & Nephew, Inc.201272
+5K112802Pipeline Total Hip SystemPipeline Orthopedics201253—
+5K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114—
+5K103431Coren Total Hip SystemCorentec Co., Ltd.201111—
+5K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+5K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+5K103721Mpact Acetabular SystemMedacta International201121—
+5K103518Trinity Acetabular SystemCorin USA20118—
+5K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.201033—
+5K102423Depuy Pinnacle Altrx Acetabular LinersDePuy Orthopaedics, Inc.2010172
+5K101575Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810…Omnlife Science201024—
+5K101451Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc.20104—
+5K100555Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKOmni Life Science, Inc.2010341
+5K093646Depuy Pinnacle with Gription Acetabular CupsDePuy Orthopaedics, Inc.200931—
+5K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc.20093—
+5K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+5K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+5K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+5K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+5K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.200883—
+5K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.200779—
+5K062684Excia Total Hip System 36MM Ceramic HeadAesculap, Inc.200665—
+5K061344Excia Total Hip System Lateral OffsetAesculap, Inc.20064—
+5K060707Aesculap Bipolar Acetabular CupAesculap, Inc.200611—
+5K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc.200690—
+5K060437Excia Total Hip System with U-CapAesculap, Inc.200690—
+6K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+6K252451EPORE® XO cup systemImplantcast GmbH20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20250—
+6K250450Coated hip implantsMedacta International S.A.20250—
+6K241461Mpact Constrained LinerMedacta International S.A.20251—
+6K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+6K243809Biolox® Delta Revision headsLimacorporate20250—
+6K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+6K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+6K241472Icona Hip StemCorin U.S.A. Limited20241—
+6K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+6K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+6K230011Mpact ExtensionMedacta International S.A.20233—
+6K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+6K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+6K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+6K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+6K210678implaFit® hip stemsImplantcast GmbH20223—
+6K221794Vario-Cup SystemWaldemar Link GmbH & Co. KG20220—
+6K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+6K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.20220—
+6K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+6K201157Prime BIOFOAM® Multi-Hole ShellsMicroport Orthopedics, Inc.20210—
+6K202705Prime and DYNASTY® Additive Manufacturing ShellsMicroport Orthopedics, Inc.20210—
+6K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+6K200391MPACT ExtensionMedacta International S.A.20210—
+6K203420EcoFit® Hip SystemImplantcast GmbH20214—
+6K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+6K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+6K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+6K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190—
+6K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+6K191002OR3O Dual Mobility SystemSmith & Nephew, Inc.20195—
+6K191569Implantcast ic-Bipolar Head SystemImplantcast GmbH20193—
+6K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+6K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+6K190123MicroPort CoCr Femoral HeadsMicroport Orthopedics, Inc.20191—
+6K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+6K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181—