510(k) Report

Devices descending from K061253

120 later devices reach Reflection 3 Acetabular System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+1K201701R3 HA Coated Acetabular ShellsSmith & Nephew, Inc.20200—
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+1K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+1K113848R3 Xlpe LinersSmith & Nephew, Inc.201272
+1K100933Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc.201035—
+1K092265Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersMedacta International S.A.201023—
+1K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc.201016—
+1K092098Patient Specific Acetabular Reconstruction ProsthesisSmith & Nephew, Inc.20101—
+1K092386R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSmith & Nephew, Inc.200946—
+1K070756Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc.2007916
+2K241461Mpact Constrained LinerMedacta International S.A.20251—
+2K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+2K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+2K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+2K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+2K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+2K213842ONVOY Acetabular SystemGlobus Medical, Inc.20221—
+2K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+2K211330R3 Large Head LinersSmith & Nephew, Inc.20220—
+2K182535R3 Anteverted LinersSmith & Nephew, Inc.20184—
+2K182109REDAPT Modular Acetabular ShellSmith & Nephew, Inc.20184—
+2K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+2K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+2K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+2K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.20170—
+2K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc.20166—
+2K150790REDAPT Porous Acetabular Shell and Cemented LinerSmith & Nephew, Inc.201513—
+2K143453Mpact Double Mobility SystemMedacta International20151—
+2K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+2K131458Mpact DM Liner ConverterMedacta International20133—
+2K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+2K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123—
+2K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+2K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114—
+2K111546U2 Hip SystemUnited Orthopedic Corp.2011131
+2K110101Taper Oxinium Femoral HeadSmith & Nephew, Inc.20115—
+2K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+2K103721Mpact Acetabular SystemMedacta International201121—
+2K103352Versafitcup CC TrioMedacta International20114—
+2K102370R3 Xlpe Anteverted LinersSmith & Nephew, Inc.20116—
+2K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+2K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.201033—
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+3K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+3K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20250—
+3K250450Coated hip implantsMedacta International S.A.20250—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+3K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+3K230011Mpact ExtensionMedacta International S.A.20233—
+3K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+3K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+3K211891DM Converter - TiN coatedMedacta International S.A.20220—
+3K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+3K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+3K200391MPACT ExtensionMedacta International S.A.20210—
+3K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+3K191002OR3O Dual Mobility SystemSmith & Nephew, Inc.20195—
+3K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+3K183582MPACT ExtensionMedacta International S.A.20194—
+3K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+3K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+3K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+3K171073Smith & Nephew, Inc. REDAPT AugmentsSmith & Nephew, Inc.20175—
+3K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+3K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+3K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+3K160923REDAPT Anteverted Cemented LinerSmith & Nephew, Inc.20164—
+3K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+3K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+3K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+3K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+3K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+3K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+3K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+3K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+3K132879Mpact ExtensionMedacta International201411—
+3K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+3K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+3K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+3K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc.20120—
+3K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+3K122911Versafitcup CC Trio ExtensionMedacta International20121—
+3K122504Femoral Heads, 2.5 and 7.5 MM Neck LengthUnited Orthopedic Corporation20123—
+3K122641Mpact ExtensionMedacta International201214—
+3K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.201220—
+3K121263Taper Set Hip System RDP StemConsensus Orthopedics, Inc.20120—
+3K111145Endo HeadMedacta International20110—
+4K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+4K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+4K243809Biolox® Delta Revision headsLimacorporate20250—
+4K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+4K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+4K190847REDAPT Blade AugmentsSmith & Nephew, Inc.20190—
+4K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+4K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+4K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+4K163577Ecofit® Hip SystemImplantcast GmbH201791