510(k) Report

Devices descending from K983014

404 later devices reach Summit Acetabular System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+4K171273LINK® BiMobile (TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG201842
+4K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+4K163577Ecofit® Hip SystemImplantcast GmbH201791
+4K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+4K170444PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc.201716—
+4K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc.20166—
+4K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+4K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20161—
+4K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20160—
+4K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+4K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+4K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+4K142761Corin TaperFit Hip StemCorin USA201541
+4K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+4K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+4K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+4K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+4K141395Delta TT Acetabular SystemLima Corporate S.P.A.2014101
+4K141043CS2 Multi-Hole Acetabular ShellConsensus Orthopedics, Inc.201421—
+4K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+4K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+4K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K131647Trinity Acetabular SystemCorin USA201322—
+4K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+4K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+4K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+4K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+4K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+4K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+4K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123—
+4K121563Corin Trifit TS HipCorin USA2012101
+4K113848R3 Xlpe LinersSmith & Nephew, Inc.201272
+4K112802Pipeline Total Hip SystemPipeline Orthopedics201253—
+4K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114—
+4K103431Coren Total Hip SystemCorentec Co., Ltd.201111—
+4K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+4K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+4K103721Mpact Acetabular SystemMedacta International201121—
+4K103518Trinity Acetabular SystemCorin USA20118—
+4K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.201033—
+4K102423Depuy Pinnacle Altrx Acetabular LinersDePuy Orthopaedics, Inc.2010172
+4K101575Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810…Omnlife Science201024—
+4K101451Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc.20104—
+4K100555Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKOmni Life Science, Inc.2010341
+4K093646Depuy Pinnacle with Gription Acetabular CupsDePuy Orthopaedics, Inc.200931—
+4K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc.20093—
+4K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+4K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+4K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+4K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+4K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.200883—
+4K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.200779—
+4K062684Excia Total Hip System 36MM Ceramic HeadAesculap, Inc.200665—
+4K061344Excia Total Hip System Lateral OffsetAesculap, Inc.20064—
+4K060707Aesculap Bipolar Acetabular CupAesculap, Inc.200611—
+4K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc.200690—
+4K060437Excia Total Hip System with U-CapAesculap, Inc.200690—
+5K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+5K252451EPORE® XO cup systemImplantcast GmbH20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20250—
+5K250450Coated hip implantsMedacta International S.A.20250—
+5K241461Mpact Constrained LinerMedacta International S.A.20251—
+5K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+5K243809Biolox® Delta Revision headsLimacorporate20250—
+5K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+5K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+5K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+5K230011Mpact ExtensionMedacta International S.A.20233—
+5K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+5K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+5K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+5K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+5K210678implaFit® hip stemsImplantcast GmbH20223—
+5K221794Vario-Cup SystemWaldemar Link GmbH & Co. KG20220—
+5K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+5K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.20220—
+5K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+5K201157Prime BIOFOAM® Multi-Hole ShellsMicroport Orthopedics, Inc.20210—
+5K202705Prime and DYNASTY® Additive Manufacturing ShellsMicroport Orthopedics, Inc.20210—
+5K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+5K200391MPACT ExtensionMedacta International S.A.20210—
+5K203420EcoFit® Hip SystemImplantcast GmbH20214—
+5K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+5K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+5K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+5K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190—
+5K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+5K191002OR3O Dual Mobility SystemSmith & Nephew, Inc.20195—
+5K191569Implantcast ic-Bipolar Head SystemImplantcast GmbH20193—
+5K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+5K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+5K190123MicroPort CoCr Femoral HeadsMicroport Orthopedics, Inc.20191—
+5K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+5K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181—
+5K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—